Chrysalis Intelligence · Sponsors · Becton, Dickinson and Company

Becton, Dickinson and Company

Franklin Lakes, NJ, US · 64 510(k) clearances · 25 PMAs · 4 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
64
2020-07-15 → 2026-09-14
Last 12 months
8
Product codes
26
Most recent
2026-09-14
Name variants in FDA filings: Becton Dickinson and Company / Becton, Dickinson and Company
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Class II Clinical Chemistry 16 2026-04-15
FMF Syringe, Piston Class II General Hospital 5 2025-07-29
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class II Microbiology 4 2025-08-08
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 4 2022-12-28
GIM Tubes, Vacuum Sample, With Anticoagulant Class II Clinical Chemistry 3 2024-10-31
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Class II Anesthesiology 3 2022-07-01
NGT Saline, Vascular Access Flush Class II General Hospital 2 2025-12-02
PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System Class II Microbiology 2 2025-10-31
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Class II General Hospital 2 2025-09-12
PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Class II Microbiology 2 2024-12-19
QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry Class II Microbiology 2 2023-08-31
JTN Susceptibility Test Discs, Antimicrobial Class II Microbiology 2 2023-06-07
MDB System, Blood Culturing Class I Microbiology 2 2023-03-24
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Class II Microbiology 2 2022-09-21
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class II General Hospital 2 2021-06-02
JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Class II Microbiology 1 2026-09-14
SEP Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay Class II Microbiology 1 2026-04-02
QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Class II Microbiology 1 2025-06-16
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 1 2022-12-16
QTI Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device Class II General Hospital 1 2022-07-16
CAZ Anesthesia Conduction Kit Class II Anesthesiology 1 2022-05-19
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Class II Microbiology 1 2022-05-10
FQH Lavage, Jet Class II General Hospital 1 2022-03-23
QBP Cap, Device Disinfectant Class II General Hospital 1 2020-11-09
OYE Flow Cytometric Reagents And Accessories. Class II Hematology 1 2020-09-28
QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact Class II General Hospital 1 2020-09-04
Class III

PMA approvals (25)

Total PMA records
25
Originals + supplements
Distinct product codes
1
First decision
2020-03-19
Most recent
2026-08-19
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-19 P160037-S027 BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074) Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-08-14 P160037-S028 BD Onclarity™ HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-04-02 P160037-S025 BD Onclarity HPV Assay Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-04-02 P160037-S024 BD Onclarity HPV Assay Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-02-12 P160037-S026 BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-08-25 P160037-S022 BD ONCLARITY HPV ASSAY Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-07-02 P160037-S023 BD Onclarity HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-03-12 P160037-S021 Onclarity HPV Assay Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-11-05 P160037-S020 BD Onclarity™ HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-05-14 P160037-S017 BD Onclarity HPV Assay Panel Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-04-18 P160037-S019 BD Onclarity™ HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-11-20 P160037-S018 BD Onclarity HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-11-15 P160037-S016 BD Onclarity HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-04-12 P160037-S014 BD Onclarity HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-02-27 P160037-S015 BD Onclarity™ HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-02-15 P160037-S012 BD Onclarity™ HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-02-09 P160037-S008 BD Onclarity HPV Assay Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2022-12-07 P160037-S013 BD Onclarity HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2022-11-19 P160037-S011 BD Onclarity™ HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2022-01-24 P160037-S010 BD Onclarity™ HPV Assay Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2021-08-24 P160037-S005 BD Onclarity HPV Assay/BD COR System Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-10-13 P160037-S009 BD Onclarity HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-08-03 P160037-S007 BD Onclarity HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-06-12 P160037-S004 BD Onclarity HPV Assay Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-03-19 P160037-S006 BD Onclarity HPV Assay 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2026-08-11
DateSeverityStatusRecall # ProductCodeReason
2026-08-11 Class II Ongoing Z-3250-2026 ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter c… — Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
2026-04-08 Class II Ongoing Z-2204-2026 Swan-Ganz Pacing Catheter, Models: D200F7; — Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medica…
2026-04-08 Class II Ongoing Z-2203-2026 Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P — Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medica…
2026-04-08 Class II Ongoing Z-2202-2026 Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 83… — Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medica…
Filings

All 510(k) clearances (64)

Date K-number Device Code Class Specialty
2026-09-14 K262163 BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth JTZ Class II Microbiology
2026-04-15 K260128 BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes JKA Class II Clinical Chemistry
2026-04-10 K252506 BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder JKA Class II Clinical Chemistry
2026-04-10 K252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube JKA Class II Clinical Chemistry
2026-04-02 K260184 Onclarity™ Self-Collection Kit SEP Class II Microbiology
2026-03-13 K252040 BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes JKA Class II Clinical Chemistry
2025-12-02 K250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe NGT Class II General Hospital
2025-10-31 K250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System PCI Class II Microbiology
2025-09-12 K250059 BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) ONB Class II General Hospital
2025-08-08 K251713 BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) LON Class II Microbiology
2025-07-29 K251350 BD Plastipak™ Syringe FMF Class II General Hospital
2025-07-03 K243207 BD Vacutainer® Eclipse™ Blood Collection Needle JKA Class II Clinical Chemistry
2025-06-16 K243872 BD Veritor System for SARS-CoV-2 QVF Class II Microbiology
2025-05-19 K250447 BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) LON Class II Microbiology
2025-03-21 K243649 BD Vacutainer® Multiple Sample Luer Adapter JKA Class II Clinical Chemistry
2025-03-06 K250344 BD Phoenix™ Automated Microbiology System LON Class II Microbiology
2024-12-19 K243725 BD Vaginal Panel PQA Class II Microbiology
2024-11-01 K242320 BD Vacutainer® One Use Holder JKA Class II Clinical Chemistry
2024-10-31 K240455 BD Vacutainer® Citrate Blood Collection Tubes GIM Class II Clinical Chemistry
2024-03-15 K233986 BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) LON Class II Microbiology
2024-02-02 K231373 BD Vacutainer® K2 EDTA Blood Collection Tubes JKA Class II Clinical Chemistry
2024-01-19 K231237 BD Vacutainer® Fluoride Blood Collection Tubes JKA Class II Clinical Chemistry
2023-12-20 K230855 BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes JKA Class II Clinical Chemistry
2023-12-01 K230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube JKA Class II Clinical Chemistry
2023-11-27 K230493 BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube GIM Class II Clinical Chemistry
2023-08-31 K222563 BD Kiestra IdentifA QQV Class II Microbiology
2023-08-25 K213670 BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes GIM Class II Clinical Chemistry
2023-07-21 K231161 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe NGT Class II General Hospital
2023-07-17 K213953 BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes JKA Class II Clinical Chemistry
2023-06-07 K230651 BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) JTN Class II Microbiology
2023-03-24 K222591 BD BACTEC™ Plus Aerobic/F Culture Vials MDB Class I Microbiology
2023-03-24 K222559 BD BACTEC™ Myco/F Lytic Culture Vials MDB Class I Microbiology
2023-03-24 K220212 BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder JKA Class II Clinical Chemistry
2023-03-10 K222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device JKA Class II Clinical Chemistry
2023-03-06 K223653 BD Vaginal Panel PQA Class II Microbiology
2022-12-28 K223286 BD AutoShield Duo™ Pen Needle FMI Class II General Hospital
2022-12-21 K221826 BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) JTN Class II Microbiology
2022-12-16 K223243 BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets FMK Class II General, Plastic Surgery
2022-09-21 K220607 BD MAX Enteric Viral Panel PCH Class II Microbiology
2022-08-19 K220193 BD MAX Enteric Parasite Panel PCH Class II Microbiology
2022-07-28 K214122 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel PCI Class II Microbiology
2022-07-16 K213955 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub QTI Class II General Hospital
2022-07-01 K211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle BSP Class II Anesthesiology
2022-06-28 K213478 BD Pen Needle FMI Class II General Hospital
2022-05-19 K210983 BD Epilor Syringe CAZ Class II Anesthesiology
2022-05-10 K210585 BD CTGCTV2 QEP Class II Microbiology
2022-03-23 K213616 BD Surgiphor Antimicrobial Irrigation System FQH Class II General Hospital
2022-03-09 K212499 BD Insulin Syringe (0.3mL) FMF Class II General Hospital
2022-02-04 K212724 BD Vacutainer UltraTouch Push Button Blood Collection Set JKA Class II Clinical Chemistry
2021-12-22 K210978 BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle BSP Class II Anesthesiology
2021-12-08 K213156 BD Nano 2nd Gen Pen Needle FMI Class II General Hospital
2021-11-19 K212015 BD Nano 2nd Gen Pen Needle FMI Class II General Hospital
2021-11-03 K191964 BD Kiestra IdentifA QQV Class II Microbiology
2021-07-28 K203359 BD Flu+ Syringe FMF Class II General Hospital
2021-06-02 K200891 BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System FOZ Class II General Hospital
2021-01-25 K203453 BD Hypodermic Syringe FMF Class II General Hospital
2020-12-18 K201075 BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter FOZ Class II General Hospital
2020-11-09 K193190 BD PureHub Disinfecting Cap QBP Class II General Hospital
2020-09-29 K193131 BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle BSP Class II Anesthesiology
2020-09-28 K201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit OYE Class II Hematology
2020-09-25 K202446 BD Preset Syringe & BD A-Line Syringe JKA Class II Clinical Chemistry
2020-09-04 K192538 BD Syringe NRFit Lok and BD Syringe NRFit Slip QEH Class II General Hospital
2020-08-12 K201099 BD PhaSeal Optima Closed System Drug Transfer Device ONB Class II General Hospital
2020-07-15 K201234 BD SoloShot Mini Syringe/ BD Auto Disable Syringe FMF Class II General Hospital
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence