Becton, Dickinson and Company · Chrysalis Intelligence

Total clearances

2020-07-15 → 2026-04-15

Last 12 months

Product codes

Most recent

2026-04-15

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	—	—	—	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	—	—	—	3	2022-07-01
NGT	Saline, Vascular Access Flush	Class II	General Hospital	2	2025-12-02
PCI	—	—	—	2	2025-10-31
ONB	—	—	—	2	2025-09-12
PQA	—	—	—	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
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	—	—	—	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	—	—	—	1	2022-07-16
CAZ	Anesthesia Conduction Kit	Class II	Anesthesiology	1	2022-05-19
QEP	—	—	—	1	2022-05-10
FQH	Lavage, Jet	Class II	General Hospital	1	2022-03-23
QBP	—	—	—	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 (24)

Total PMA records

Originals + supplements

Distinct product codes

First decision

2020-03-19

Most recent

2026-08-14

Date	PMA #	Trade name	Type	Code	Device name	Specialty
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 (3)

Class I (serious)

Risk of injury / death

Total recalls

Currently ongoing

Most recent

2026-04-08

Date	Severity	Status	Recall #	Product	Code	Reason
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 (63)

Date	K-number	Device	Code	Class	Specialty
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	—	—
2025-09-12	K250059	BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)	ONB	—	—
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	—	—
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	—	—
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	—	—
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 (0.01564 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	—	—
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	—	—
2022-07-16	K213955	0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub	QTI	—	—
2022-07-01	K211085	BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle	BSP	—	—
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	—	—
2022-03-23	K213616	BD Surgiphor Antimicrobial Irrigation System	FQH	Class II	General Hospital
2022-03-09	K212499	BD Insulin Syringe (0.3mL)	FMF	—	—
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	—	—
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	—	—
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	—	—
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	—	—
2020-09-29	K193131	BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle	BSP	—	—
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	—	—
2020-07-15	K201234	BD SoloShot Mini Syringe/ BD Auto Disable Syringe	FMF	—	—