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

Kci USA, Inc. — Predicate Candidate Screening

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

116 daysmedian FDA review time

294 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241134	3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275	Kci USA, Inc.	2024-05-23	29	0
K201571	ACTIV.A.C. Negative Pressure Wound Therapy System	Kci USA, Inc.	2020-07-08	27	0
K200390	V.A.C. DERMATAC Drape	Kci USA, Inc.	2020-05-18	90	0
K190697	PREVENA PLUS Incision Management System (No Ag); PREVENA PLU	Kci USA, Inc.	2019-11-22	249	0
DEN180013	PREVENA 125 and PREVENA PLUS 125 Therapy Units	Kci USA, Inc.	2019-04-19	400	0
K181505	V.A.C. DERMATAC Drape	Kci USA, Inc.	2019-03-28	294	0
K183543	ACTIV.A.C. Therapy Unit	Kci USA, Inc.	2019-03-20	90	0
K181507	PREVENA RESTOR(TM) Incision Management System	Kci USA, Inc.	2019-02-15	253	0
K180855	Prevena Plus Incision Management System, Prevena Plus Duo In	Kci USA, Inc.	2018-06-01	60	0
K173426	PREVENA PLUS Incision Management System, PREVENA PLUS DUO In	Kci USA, Inc.	2018-03-09	127	0
K173447	V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starte	Kci USA, Inc.	2018-03-02	116	0
K160487	V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System	Kci USA, Inc.	2016-12-09	291	0
K153199	Prevena Plus Incision Management System Kit with Peel & Plac	Kci USA, Inc.	2016-02-29	119	0
K150006	Prevena Incision Management System with Peel & Place Dressin	Kci USA, Inc.	2015-11-06	308	0
K133276	V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOA	Kci USA, Inc.	2013-11-19	26	0
K132741	V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM	Kci USA, Inc.	2013-11-15	73	0
K123507	KCI NPWT GAUZE DRESSING	Kci USA, Inc.	2013-04-04	142	0
K120033	ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERA	Kci USA, Inc.	2012-05-31	148	0
K111280	V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT	Kci USA, Inc.	2011-07-21	76	0
K100821	PREVENA INCISION MANAGEMENT SYSTEM	Kci USA, Inc.	2010-06-11	80	8
K091585	VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M825996	Kci USA, Inc.	2009-12-29	210	0
K090489	ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026	Kci USA, Inc.	2009-05-14	78	0
K083357	OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502,	Kci USA, Inc.	2009-03-04	111	0
K063740	V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M62	Kci USA, Inc.	2007-06-07	171	3
K063692	V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 34000	Kci USA, Inc.	2007-06-07	176	1
K063590	V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER	Kci USA, Inc.	2007-01-25	55	0
K063426	V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M627509	Kci USA, Inc.	2006-12-13	30	0
K053627	MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING	Kci USA, Inc.	2006-02-06	39	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