Data / Medical devices / Ireland / KCI Manufacturing
KCI Manufacturing: FDA-registered device maker in Athlone - Co. Westmeath, Ireland, 21 510(k) clearances
KCI Manufacturing is registered with the FDA (registration 3006808392) in Athlone - Co. Westmeath, Ireland. It lists 3 device types. The FDA files 21 510(k) clearances under its listings, the newest dated May 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006808392
- Address
- IDA Business andTechnology Park Dublin Road, Athlone - Co. Westmeath, Ireland, --
- 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 |
| 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 |
| 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 |
| 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 |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- All makers of Negative Pressure Wound Therapy Non-Powered Suction Apparatus
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.