KCI USA, Inc.
San Antonio, TX, US
KCI USA, INC. appears in FDA device records in San Antonio, TX. FDA records list 76 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 47 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to KCI USA, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- KCI Imports, Inc.registration
- Kinetic Concepts, Inc.510(k), recall
510(k) clearance history
Showing 50 of 76FDA records hold 76 510(k) clearances for KCI USA, Inc. between 1978 and 2024. The busiest year on record is 1997, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 1 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 4 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 5 |
| 1998 | 1 |
| 2000 | 1 |
| 2002 | 3 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2015 | 1 |
| 2016 | 2 |
| 2018 | 3 |
| 2019 | 5 |
| 2020 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241134 | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | OMP | Substantially Equivalent | |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K200390 | V.A.C. DERMATAC Drape | OMP | Substantially Equivalent | |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | OMP | Substantially Equivalent | |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | QFC | Unknown | |
| K181505 | V.A.C. DERMATAC Drape | OMP | Substantially Equivalent | |
| K183543 | ACTIV.A.C. Therapy Unit | OMP | Substantially Equivalent | |
| K181507 | PREVENA RESTOR(TM) Incision Management System | OMP | Substantially Equivalent | |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | OMP | Substantially Equivalent | |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | OMP | Substantially Equivalent | |
| 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 | |
| K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System | OMP | Substantially Equivalent | |
| 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 | |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing | OMP | Substantially Equivalent | |
| K133276 | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS | OMP | Substantially Equivalent | |
| K132741 | V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM | OMP | Substantially Equivalent | |
| K123507 | KCI NPWT GAUZE DRESSING | OMP | Substantially Equivalent | |
| K120033 | ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT | OMP | Substantially Equivalent | |
| K111280 | V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT | OMP | Substantially Equivalent | |
| K100821 | PREVENA INCISION MANAGEMENT SYSTEM | OMP | Substantially Equivalent | |
| K091585 | VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 | OMP | Substantially Equivalent | |
| K090489 | ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 | FTL | Substantially Equivalent | |
| K083357 | OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 | OMP | Substantially Equivalent | |
| K063740 | V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 | OMP | Substantially Equivalent | |
| K063692 | V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 | OMP | Substantially Equivalent | |
| K063590 | V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 | OMP | Substantially Equivalent | |
| K063426 | V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 | OMP | Substantially Equivalent | |
| K053627 | MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | OMP | Substantially Equivalent | |
| K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | OMP | Substantially Equivalent | |
| K041642 | V.A.C. GRANUFOAM SILVER DRESSING | OMP | Substantially Equivalent | |
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS | OMP | Substantially Equivalent | |
| K022011 | V.A.C. ABDOMINAL DRESSING | FTL | Substantially Equivalent | |
| K021500 | VACUUM ASSISTED CLOSURE | OMP | Substantially Equivalent | |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | OMP | Substantially Equivalent | |
| K020781 | WET CHAMBER | NAD | Substantially Equivalent | |
| K992448 | V.A.C. PLUS | OMP | Substantially Equivalent | |
| K972176 | HOME CARE BEAD BED | INX | Substantially Equivalent | |
| K972549 | SIMPULSE | FNM | Substantially Equivalent | |
| K955243 | BARIAIR | FNM | Substantially Equivalent | |
| K970468 | KT AIR BED | FNM | Substantially Equivalent | |
| K954320 | MODIFIED PEDIKAIR | FNM | Substantially Equivalent | |
| K971548 | AMBUVAC | OMP | Substantially Equivalent | |
| K953850 | REDOX | JOW | Substantially Equivalent | |
| K944567 | COWBOY X | JOW | Substantially Equivalent | |
| K944094 | TRIADYNE | FNM | Substantially Equivalent | |
| K945062 | VACPLUS | JCX | Substantially Equivalent | |
| K945664 | BARIKARE PLUS | FNL | Substantially Equivalent | |
| K940886 | ANNELID | JCX | Substantially Equivalent | |
| K933402 | TURBO II | FNM | Substantially Equivalent | |
| K931581 | GLENN BED | FNL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009778650 | 3009897021 | KCI Imports, Inc. | 12930 IH 10 West, San Antonio, TX 78249 US | 2026 | No device listings on this registration |
| 3005178245 | 3005178245 | KCI USA, INC. | 6203 FARINON DR., SAN ANTONIO, TX 78249 US | 2026 | |
| 3009897021 | 3009897021 | KCI USA, INC. | 12930 IH 10 West, San Antonio, TX 78249 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- FNLBed, Ac-Powered Adjustable Hospital
- INXBed, Air Fluidized
- IOQBed, Flotation Therapy, Powered
- FNJBed, Manual
- INYBed, Patient Rotation, Manual
- IKZBed, Patient Rotation, Powered
- CBHDevice, Fixation, Tracheal Tube
- NADDressing, Wound, Occlusive
- EQNLaryngoscope, Nasopharyngoscope
- FNMMattress, Air Flotation, Alternating Pressure
- FTLMesh, Surgical, Polymeric
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- ILOPack, Hot Or Cold, Water Circulating
- JOWSleeve, Limb, Compressible
- IROVibrator, Therapeutic
- FMTWarmer, Infant Radiant
- ITIWheelchair, Powered
Recall records
Showing 25 of 47| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1176-2025 | 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper | Due to increase in complaints related to leak alarms | Class II | Open, Classified | |
| Z-1175-2025 | 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 system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM | Due to increase in complaints related to leak alarms | Class II | Open, Classified | |
| Z-0507-2025 | 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 option. | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. | Class II | Open, Classified | |
| Z-2542-2020 | 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 used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. | Class II | Terminated | |
| Z-2171-2017 | 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 acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister | Potential sterile barrier breach | Class II | Terminated | |
| Z-0600-2016 | 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 therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. | There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters. | Class II | Terminated | |
| Z-0933-2015 | 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 skin graft for autologous skin grafting. | 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. | Class II | Terminated | |
| Z-0070-2015 | 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. | Class II | Terminated | |
| Z-2717-2014 | CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 | Blade can shift during shipping which makes the product ineffective. | Class II | Terminated | |
| Z-1142-2014 | PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1141-2014 | PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1140-2014 | PRE2055: Prevena Customizable Dressing 5-Pack 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1139-2014 | PRE2001: Prevena Incision Management Customizable System Box 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1138-2014 | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1137-2014 | PRE1055: Prevena Dressing, 5 Pack 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1136-2014 | PRE1001US: Prevena Peel and Place System Kit (US-ONLY) 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-1135-2014 | 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 maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. | 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 | Class II | Terminated | |
| Z-2466-2012 | BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy. | KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allow | Class II | Terminated | |
| Z-0409-2013 | RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction | The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers. | Class II | Terminated | |
| Z-1431-2012 | Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift | The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation. | Terminated | ||
| Z-2182-2011 | KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications. | Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user. | Terminated | ||
| Z-0611-2011 | RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility. | Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient. | Terminated | ||
| Z-0667-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord M426884 used with VAC ATS Canadian Model M8259994. | Power cords may crack and fail inside plug with potential for fire hazard. | Terminated | ||
| Z-0666-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968. | Power cords may crack and fail inside plug with potential for fire hazard. | Terminated | ||
| Z-0665-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013. | Power cords may crack and fail inside plug with potential for fire hazard. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets KCI USA, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain