Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cardinalhealth — Predicate Candidate Screening

32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

132 daysmedian FDA review time

265 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252313	Cardinal Health Nitrile Examination Gloves Extended Cuff	Cardinalhealth	2026-01-14	173	0
K243660	Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777);	Cardinalhealth	2025-08-22	268	0
K243652	Monoject™ Enteral Syringe with ENFit Connector (401SE); Mono	Cardinalhealth	2024-12-19	23	0
K230569	Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level	Cardinalhealth	2023-07-03	124	0
K213174	Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Conne	Cardinalhealth	2022-05-19	233	0
K202217	Kendall NPWT Incision Management Device	Cardinalhealth	2021-06-04	302	0
K191101	Kendall NPWT Incision Management Dressing Kit	Cardinalhealth	2020-07-31	463	0
K190923	Salem Sump Dual Lumen Stomach Tube with ENFit Connection	Cardinalhealth	2019-11-07	212	1
K171499	Occlusion Detection Dressing Kit	Cardinalhealth	2017-09-22	122	0
K161418	Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health	Cardinalhealth	2017-01-19	241	0
K150769	Cardinal Health Trochanteric IM Nail System	Cardinalhealth	2015-12-14	265	0
K150124	Cardinal Health NPWT PRO HC	Cardinalhealth	2015-09-02	225	0
K150579	Cardinal Health External Fixation System	Cardinalhealth	2015-04-29	51	0
K143016	Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Ca	Cardinalhealth	2015-04-20	182	0
K142916	SVED Wound Treatment System	Cardinalhealth	2015-03-04	148	0
K081464	STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SER	Cardinalhealth	2008-08-28	93	0
K080845	ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM	Cardinalhealth	2008-04-30	35	0
K072119	AIRLIFE NEBULIZER CAP	Cardinalhealth	2007-08-10	9	0
K053272	CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOV	Cardinalhealth	2006-01-05	43	0
K052568	ESTEEM STRETCHY VINYL GLOVE WITH COATING	Cardinalhealth	2005-11-28	70	0
K051226	AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SY	Cardinalhealth	2005-11-17	189	2
K050994	AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYS	Cardinalhealth	2005-08-03	106	0
K043518	RADIOPAQUE BONE CEMENT	Cardinalhealth	2005-05-11	142	0
K042574	ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTA	Cardinalhealth	2004-12-08	77	8
K041418	AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER	Cardinalhealth	2004-06-10	14	0
K040152	BONE CEMENT FOR CRANIOPLASTY	Cardinalhealth	2004-05-19	117	0
K033789	LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING	Cardinalhealth	2004-05-07	155	0
K033905	PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING	Cardinalhealth	2004-04-27	132	0
K032444	NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING A	Cardinalhealth	2003-11-13	97	0
K032388	BONE CEMENT RADIO-OPACIFIER	Cardinalhealth	2003-10-31	88	0
K031301	ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING	Cardinalhealth	2003-10-15	174	0
K031468	TEMPORARY TITANIUM ANEURYSM CLIP	Cardinalhealth	2003-06-20	42	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda