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 3009897021) 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. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009897021
Address: 12930 IH 10 West, San Antonio, TX, United States, 78249
Owner or operator: Solventum US LLC (10091183)
Roles: Manufacturer
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	Manufacturer	accessdata.fda.gov
Negative Pressure Wound Therapy Non-Powered Suction Apparatus	OKO	2	Manufacturer	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Manufacturer	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
January 17, 2025	96070	Class II	Ongoing	3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm sys	Due to increase in complaints related to leak alarms	accessdata.fda.gov
November 5, 2024	95580	Class II	Ongoing	V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation o	Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.	accessdata.fda.gov
June 8, 2020	85734	Class II	Terminated	ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When	The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.	accessdata.fda.gov
April 28, 2017	77159	Class II	Terminated	1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in	Potential sterile barrier breach	accessdata.fda.gov
November 25, 2015	72753	Class II	Terminated	ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound	There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.	accessdata.fda.gov
November 19, 2014	69961	Class II	Terminated	CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin sk	KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.	accessdata.fda.gov
January 30, 2014	67454	Class II	Terminated	PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing	accessdata.fda.gov

Compare with other makers

Updated February 14, 2025. 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.