Chrysalis Intelligence · Sponsors · Cardinalhealth

Cardinalhealth

Waukegan, IL, US · 7 510(k) clearances · 1 PMAs

Total clearances
7
2020-07-31 → 2026-01-14
Last 12 months
1
Product codes
6
Most recent
2026-01-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OMP Negative Pressure Wound Therapy Powered Suction Pump Class II General, Plastic Surgery 2 2021-06-04
LZC 1 2026-01-14
FMF 1 2025-08-22
PNR Enteral Syringes With Enteral Specific Connectors Class II Gastroenterology, Urology 1 2024-12-19
FXX 1 2023-07-03
PIF Gastrointestinal Tubes With Enteral Specific Connectors Class II Gastroenterology, Urology 1 2022-05-19
Class III

PMA approvals (1)

Total PMA records
1
Originals + supplements
Distinct product codes
1
First decision
2020-08-07
Most recent
2020-08-07
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2020-08-07 P190007 Cardinal Health Multifunctional Defibrillation Electrode Original MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-01-14 K252313 Cardinal Health Nitrile Examination Gloves Extended Cuff LZC
2025-08-22 K243660 Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec FMF
2024-12-19 K243652 Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) PNR Class II Gastroenterology, Urology
2023-07-03 K230569 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) FXX
2022-05-19 K213174 Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection PIF Class II Gastroenterology, Urology
2021-06-04 K202217 Kendall NPWT Incision Management Device OMP Class II General, Plastic Surgery
2020-07-31 K191101 Kendall NPWT Incision Management Dressing Kit OMP Class II General, Plastic Surgery