Convatec, A Bristol-Myers Squibb Co.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Convatec, A Bristol-Myers Squibb Co.” (first 1994, latest 2004), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 Convatec, 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 2 | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Review panels
Most recent Convatec, A Bristol-Myers Squibb Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032734 | CONVATEC FECAL MANAGEMENT SYSTEM | KNT | 2004-04-08 | 217 |
| K990368 | DUODERM HYDROACTIVE GEL WOUND DRESSING | MGQ | 1999-03-26 | 46 |
| K982116 | AQUACEL HYDROFIBER WOUND DRESSING | KMF | 1998-09-08 | 84 |
| K973806 | DUODERM HYDROACTIVE GEL | MGQ | 1997-12-29 | 84 |
| K973807 | DUODERM HYDROACTIVE PASTE | FRO | 1997-12-23 | 78 |
| K973717 | COMBIDERM ACD | FRO | 1997-12-17 | 79 |
| K973716 | DUODERM EXTRA THIN CGF DRESSING | FRO | 1997-12-17 | 79 |
| K954918 | COMBIDERM ACD | KMF | 1995-12-26 | 61 |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | EXJ | 1995-03-17 | 268 |
| K940895 | EPIVIEW | MGP | 1994-11-22 | 271 |
Recalls
openFDA lists no recalls under a recalling firm named Convatec, A Bristol-Myers Squibb Co..
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.
- Convatec, A Division of E.R. Squibb & Sons (84 510(k)s)
- Convatec (19 510(k)s)
- Convatec Limited (10 510(k)s)
- Convatec Limited, Gdc Building (1 510(k)s)
- Convatec Triad Life Sciences, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Convatec, A Bristol-Myers Squibb Co.?
FDA lists 10 510(k) clearances under the applicant name “Convatec, A Bristol-Myers Squibb Co.” (first 1994, latest 2004), across 6 product codes in 2 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 Convatec, A Bristol-Myers Squibb Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Convatec, A Bristol-Myers Squibb Co. is 82 days.
Which FDA product codes appear under Convatec, A Bristol-Myers Squibb Co.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 3); KMF (Bandage, Liquid, 2); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 2).
Next steps
- See all 10 Convatec, A Bristol-Myers Squibb Co. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Convatec, A Bristol-Myers Squibb Co.'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.