Data / Medical devices / United States / Kci Usa, Inc.

Kci Usa, Inc.: FDA-registered device maker in San Antonio, TX, United States, 24 510(k) clearances

Name: Kci Usa, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kci Usa, Inc. is registered with the FDA (registration 3005178245) in San Antonio, TX, United States. It lists 3 device types. The FDA files 24 510(k) clearances under its listings, the newest dated May 23, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005178245
Address: 6203 Farinon DR., San Antonio, TX, United States, 78249
Owner or operator: Solventum US LLC (10091183)
Roles: Complaint file establishment, Specification developer
First device listed: October 31, 2019
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications	QFC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Negative Pressure Wound Therapy Non-Powered Suction Apparatus	OKO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 23, 2024	K241134	3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
March 23, 2023	K222859	3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)	OMP	Substantially Equivalent	3M	accessdata.fda.gov
March 23, 2023	K221585	3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit	OMP	Substantially Equivalent	3M Healthcare Business Group	accessdata.fda.gov
February 13, 2023	K223263	Prevena Plus 125 Therapy Unit	QFC	Substantially Equivalent	3M	accessdata.fda.gov
July 14, 2022	K220560	Dermatac Drape	OMP	Substantially Equivalent	3M	accessdata.fda.gov
July 1, 2022	K220660	Prevena Restor Adapti-Form Dressing	OMP	Substantially Equivalent	3M Healthcare Business Group	accessdata.fda.gov
October 27, 2021	K203316	V.A.C.ULTA Negative Pressure Wound Therapy System	OMP	Substantially Equivalent	Kci, A Part of 3M Health Care Business Group	accessdata.fda.gov
September 28, 2021	K212320	Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac	OMP	Substantially Equivalent	3M Healthcare Business Group	accessdata.fda.gov
July 8, 2020	K201571	ACTIV.A.C. Negative Pressure Wound Therapy System	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
March 20, 2019	K183543	ACTIV.A.C. Therapy Unit	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
February 15, 2019	K181507	PREVENA RESTOR(TM) Incision Management System	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
March 2, 2018	K173447	V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
December 9, 2016	K160487	V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
October 4, 2016	K161897	PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings	OMP	Substantially Equivalent	Kci USA, Inc. (Kinetic Concepts, Inc.)	accessdata.fda.gov
February 29, 2016	K153199	Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
November 19, 2015	K151710	SNaP Wound Care System	OKO	Substantially Equivalent	Spiracur, Inc.	accessdata.fda.gov
November 6, 2015	K150006	Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
August 20, 2015	K141017	PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,	OMP	Substantially Equivalent	Kci USA, Inc. (Kinetic Concepts, Inc.)	accessdata.fda.gov
October 11, 2012	K121883	PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT	OMP	Substantially Equivalent	Kci USA, Inc. (Kinetic Concepts, Inc.)	accessdata.fda.gov
October 5, 2012	K120499	ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM	OMP	Substantially Equivalent	Kci USA, Inc. (Kinetic Concepts, Inc.)	accessdata.fda.gov
May 31, 2012	K120033	ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov
March 14, 2011	K103156	V.A.C. VERAFLO CLEANSE DRESSING SYSTEM	OMP	Substantially Equivalent	Kci USA, Inc. (Kinetic Concepts, Inc.)	accessdata.fda.gov
September 17, 2010	K100657	V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U	OMP	Substantially Equivalent	Kci USA, Inc. (Kinetic Concepts, Inc.)	accessdata.fda.gov
June 11, 2010	K100821	PREVENA INCISION MANAGEMENT SYSTEM	OMP	Substantially Equivalent	Kci USA, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 18, 2014	69368	Class II	Terminated	V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.	A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.	accessdata.fda.gov
May 19, 2014	68329	Class II	Terminated	CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50	Blade can shift during shipping which makes the product ineffective.	accessdata.fda.gov

Compare with other makers

Updated May 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.