Kci USA, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Kci USA, Inc.” (first 2006, latest 2024), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 103 days, against 162 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Solventum (formerly 3M Health Care), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 148 |
| 2013 | 3 | 73 |
| 2014 | 0 | — |
| 2015 | 1 | 308 |
| 2016 | 2 | 205 |
| 2017 | 0 | — |
| 2018 | 3 | 116 |
| 2019 | 4 | 251 |
| 2020 | 2 | 58 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kci USA, Inc. took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 26 | 26 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| QFC | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | 1 | 0 |
Review panels
Most recent Kci USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | OMP | 2024-05-23 | 29 |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | OMP | 2020-07-08 | 27 |
| K200390 | V.A.C. DERMATAC Drape | OMP | 2020-05-18 | 90 |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | OMP | 2019-11-22 | 249 |
| K181505 | V.A.C. DERMATAC Drape | OMP | 2019-03-28 | 294 |
| K183543 | ACTIV.A.C. Therapy Unit | OMP | 2019-03-20 | 90 |
| K181507 | PREVENA RESTOR(TM) Incision Management System | OMP | 2019-02-15 | 253 |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | OMP | 2018-06-01 | 60 |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | OMP | 2018-03-09 | 127 |
| 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 | 2018-03-02 | 116 |
17 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180013 | De Novo | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | 2019-04-19 |
Recalls
30 product recalls in 16 recall events; 3 initiated in the last five years. Most recent: 2025-01-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Kci USA, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05902793: Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds (Completed, started 2020-08-04)
- NCT03274466: Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty (Completed, started 2017-12-05)
- NCT01867580: A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement (Completed, started 2013-05)
- NCT01450631: The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions (Completed, started 2012-02)
- NCT01016353: Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique (Completed, started 2009-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kci USA, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Kci USA, Inc.” (first 2006, latest 2024), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kci USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kci USA, Inc. is 111 days. Since 2017: 103 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kci USA, Inc.?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 26); FTL (Mesh, Surgical, Polymeric, 1); QFC (Negative Pressure Wound Therapy Device For Reduction Of Wound Complications, 1).
Next steps
- See all 27 Kci USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OMP, Kci USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.