Company · US
Kci USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2024. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 43 |
| IOQ | Bed, Flotation Therapy, Powered | 3 |
| GFD | Dermatome | 2 |
| IKZ | Bed, Patient Rotation, Powered | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 2 |
| QFC | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | 2 |
| FMT | Warmer, Infant Radiant | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 1 |
| FSA | Lift, Patient, Non-Ac-Powered | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 2024 | K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) Kci USA, Inc. | OMP |
| Jul 8, 2020 | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System Kci USA, Inc. | OMP |
| May 18, 2020 | K200390 | V.A.C. DERMATAC Drape Kci USA, Inc. | OMP |
| Nov 22, 2019 | K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) Kci USA, Inc. | OMP |
| Apr 19, 2019 | DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units Kci USA, Inc. | QFC |
| Mar 28, 2019 | K181505 | V.A.C. DERMATAC Drape Kci USA, Inc. | OMP |
| Mar 20, 2019 | K183543 | ACTIV.A.C. Therapy Unit Kci USA, Inc. | OMP |
| Feb 15, 2019 | K181507 | PREVENA RESTOR(TM) Incision Management System Kci USA, Inc. | OMP |
| Jun 1, 2018 | K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System Kci USA, Inc. | OMP |
| Mar 9, 2018 | K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System Kci USA, Inc. | OMP |
| Mar 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 Kci USA, Inc. | OMP |
| Dec 9, 2016 | K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System Kci USA, Inc. | OMP |
| Feb 29, 2016 | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Preve Kci USA, Inc. | OMP |
| Nov 6, 2015 | K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dres Kci USA, Inc. | OMP |
| Nov 19, 2013 | K133276 | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS Kci USA, Inc. | OMP |
| Nov 15, 2013 | K132741 | V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM Kci USA, Inc. | OMP |
| Apr 4, 2013 | K123507 | KCI NPWT GAUZE DRESSING Kci USA, Inc. | OMP |
| May 31, 2012 | K120033 | ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT Kci USA, Inc. | OMP |
| Jul 21, 2011 | K111280 | V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT Kci USA, Inc. | OMP |
| Jun 11, 2010 | K100821 | PREVENA INCISION MANAGEMENT SYSTEM Kci USA, Inc. | OMP |
| Dec 29, 2009 | K091585 | VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 Kci USA, Inc. | OMP |
| May 14, 2009 | K090489 | ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 Kci USA, Inc. | FTL |
| Mar 4, 2009 | K083357 | OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 Kci USA, Inc. | OMP |
| Jun 7, 2007 | K063740 | V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 Kci USA, Inc. | OMP |
| Jun 7, 2007 | K063692 | V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 Kci USA, Inc. | OMP |
| Jan 25, 2007 | K063590 | V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 Kci USA, Inc. | OMP |
| Dec 13, 2006 | K063426 | V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 Kci USA, Inc. | OMP |
| Feb 6, 2006 | K053627 | MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING Kci USA, Inc. | OMP |
| Jul 23, 1993 | K921547 | ADVANTAGE Kci | FMT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2025 | KCI USA, INC. 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 Open, Classified |
OMP | K062227 |
| Feb 14, 2025 | KCI USA, INC. 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 Open, Classified |
QFC | K223263 |
| Nov 22, 2024 | KCI USA, INC. 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 w Open, Classified |
OMP | K162790 |
| Jun 8, 2020 | KCI USA, INC. 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 Terminated |
OMP | K183543 |
| Apr 28, 2017 | KCI USA, INC. 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 manage Terminated |
OMP | K063740 |
| Jan 6, 2016 | KCI USA, INC. 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 nega Terminated |
OMP | None listed |
| Jan 7, 2015 | KCI USA, INC. 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 repr Terminated |
GFD | None listed |
| Oct 15, 2014 | KCI USA, Inc. 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. Terminated |
OMP | None listed |
| Sep 29, 2014 | KCI USA, Inc. CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 Terminated |
GFD | None listed |
| Mar 5, 2014 | KCI USA, INC. 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 foll Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 continu Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 suture Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 f Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 suture Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 follo Terminated |
OMP | K100821 K123878 |
| Mar 5, 2014 | KCI USA, INC. 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 Terminated |
OMP | K100821 K123878 |
| Nov 20, 2012 | KCI USA, Inc. 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 Terminated |
IOQ | None listed |
| Sep 27, 2012 | KCI USA, Inc. 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 pres Terminated |
FNL | None listed |
| Apr 16, 2012 | KCI USA, Inc. Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01.
Product Usage: Human Non-AC-Powered Patient Lift Terminated |
FSA | None listed |
| May 10, 2011 | KCI USA, Inc. 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. Terminated |
IKZ | None listed |
| Dec 13, 2010 | KCI USA, Inc. 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 i Terminated |
IKZ | None listed |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord M426884 used with VAC ATS Canadian Model M8259994. Terminated |
OMP | None listed |
| Jan 25, 2010 | KCI USA, Inc. 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 825 Terminated |
OMP | K062227 K063740 |
| Jan 25, 2010 | KCI USA, Inc. 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. Terminated |
OMP | K063692 |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step Terminated |
IKY | None listed |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Mod Terminated |
IOQ | K944567 |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 40 Terminated |
IOQ | None listed |
| Sep 20, 2008 | KCI USA, Inc. 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Terminated |
JCX | K063740 |
| Sep 20, 2008 | KCI USA, Inc. 500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, In Terminated |
JCX | K063740 |