Kinetic Concepts, Inc.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Kinetic Concepts, Inc.” (first 1978, latest 2005), across 18 product codes in 6 review panels. Median 510(k) review time under this name: 128 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | 8 | 8 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 7 | 7 |
| IOQ | Bed, Flotation Therapy, Powered | 5 | 5 |
| JOW | Sleeve, Limb, Compressible | 5 | 5 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 3 | 3 |
| IKZ | Bed, Patient Rotation, Powered | 3 | 3 |
| INX | Bed, Air Fluidized | 3 | 3 |
| ILO | Pack, Hot Or Cold, Water Circulating | 2 | 2 |
| ITI | Wheelchair, Powered | 2 | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 2 | 2 |
Plus 8 more product codes.
Review panels
- Physical Medicine (17)
- General Hospital (13)
- General and Plastic Surgery (11)
- Cardiovascular (5)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
Most recent Kinetic Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | OMP | 2005-05-26 | 111 |
| K041642 | V.A.C. GRANUFOAM SILVER DRESSING | OMP | 2005-01-25 | 222 |
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS | OMP | 2003-10-10 | 74 |
| K022011 | V.A.C. ABDOMINAL DRESSING | FTL | 2003-02-26 | 252 |
| K021500 | VACUUM ASSISTED CLOSURE | OMP | 2002-12-20 | 225 |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | OMP | 2002-12-02 | 207 |
| K020781 | WET CHAMBER | NAD | 2002-05-06 | 56 |
| K992448 | V.A.C. PLUS | OMP | 2000-01-18 | 180 |
| K972176 | HOME CARE BEAD BED | INX | 1998-01-16 | 221 |
| K972549 | SIMPULSE | FNM | 1997-11-18 | 133 |
38 earlier clearances. See the full list in Caduvo.
Recalls
17 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2006-03-17.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kinetic Medical Products (63 510(k)s)
- Kinetic Biomedical Services, Inc. (5 510(k)s)
- Kinetic Technology, Inc. (5 510(k)s)
- Kinetic Instruments, Inc. (2 510(k)s)
- Kinetic Surgical, LLC (2 510(k)s)
- Kinetic Innovative Seating System, LLC (1 510(k)s)
- Kinetic Rehabilitation Instruments, Inc. (1 510(k)s)
- Kinetic Resources, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kinetic Concepts, Inc.?
FDA lists 48 510(k) clearances under the applicant name “Kinetic Concepts, Inc.” (first 1978, latest 2005), across 18 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kinetic Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kinetic Concepts, Inc. is 128 days.
Which FDA product codes appear under Kinetic Concepts, Inc.?
The most frequent FDA product codes under this applicant name are FNM (Mattress, Air Flotation, Alternating Pressure, 8); OMP (Negative Pressure Wound Therapy Powered Suction Pump, 7); IOQ (Bed, Flotation Therapy, Powered, 5).
Next steps
- See all 48 Kinetic Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNM, 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.