Kci USA, Inc. (Kinetic Concepts, Inc.): FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Kci USA, Inc. (Kinetic Concepts, Inc.)” (first 2006, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 114 days. 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 | 2 | 166 |
| 2013 | 1 | 29 |
| 2014 | 1 | 154 |
| 2015 | 1 | 486 |
| 2016 | 2 | 104 |
| 2017 | 1 | 114 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kci USA, Inc. (Kinetic Concepts, Inc.) took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 241 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 13 | 13 |
Review panels
Most recent Kci USA, Inc. (Kinetic Concepts, Inc.) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | OMP | 2017-01-26 | 114 |
| K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings | OMP | 2016-10-04 | 85 |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... | OMP | 2016-06-20 | 123 |
| K141017 | PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, | OMP | 2015-08-20 | 486 |
| K133232 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES | OMP | 2014-03-24 | 154 |
| K123878 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING | OMP | 2013-01-15 | 29 |
| K121883 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT | OMP | 2012-10-11 | 105 |
| K120499 | ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM | OMP | 2012-10-05 | 227 |
| K103156 | V.A.C. VERAFLO CLEANSE DRESSING SYSTEM | OMP | 2011-03-14 | 139 |
| K102956 | V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING | OMP | 2010-12-15 | 72 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kci USA, Inc. (Kinetic Concepts, Inc.).
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kci USA, Inc. (Kinetic Concepts, Inc.)?
FDA lists 13 510(k) clearances under the applicant name “Kci USA, Inc. (Kinetic Concepts, Inc.)” (first 2006, latest 2017), across 1 product code 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. (Kinetic Concepts, Inc.)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kci USA, Inc. (Kinetic Concepts, Inc.) is 114 days.
Which FDA product codes appear under Kci USA, Inc. (Kinetic Concepts, Inc.)?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 13).
Next steps
- See all 13 Kci USA, Inc. (Kinetic Concepts, Inc.) clearances with predicates and recalls
- Run predicate analysis for product code OMP, Kci USA, Inc. (Kinetic Concepts, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.