Convatec, A Division of E.R. Squibb & Sons: FDA filings under this applicant name
FDA lists 81 510(k) clearances under the applicant name “Convatec, A Division of E.R. Squibb & Sons” (first 1982, latest 2002), across 22 product codes in 3 review panels. Median 510(k) review time under this name: 73 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 | 13 | 13 |
| KMF | Bandage, Liquid | 13 | 13 |
| EXB | Collector, Ostomy | 9 | 9 |
| KGX | Tape And Bandage, Adhesive | 6 | 6 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 5 | 5 |
| EYQ | Garment, Protective, For Incontinence | 4 | 4 |
| LRJ | Disinfectant, Medical Devices | 4 | 4 |
| NAD | Dressing, Wound, Occlusive | 4 | 4 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 3 | 3 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 3 | 3 |
Plus 12 more product codes.
Review panels
Most recent Convatec, A Division of E.R. Squibb & Sons 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013814 | ABSORBENT ANTIMICROBIAL WOUND DRESSING | FRO | 2002-06-21 | 217 |
| K990964 | SIGNADRESS DUODERM DRESSING | KGN | 1999-05-18 | 56 |
| K984388 | HA ABSORBENT WOUND DRESSING | KGN | 1999-03-03 | 85 |
| K980720 | NONWOVEN PAD | KMF | 1998-04-15 | 50 |
| K980382 | NON-WOVEN COMPRESS | KMF | 1998-03-09 | 35 |
| K974823 | NONWOVEN DRESSING | KMF | 1998-02-20 | 58 |
| K974205 | KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON | KMF | 1998-02-06 | 88 |
| K974304 | GERMICIDAL CLOTH | LRJ | 1998-01-13 | 57 |
| K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING | FRO | 1997-12-22 | 89 |
| K972530 | CONVATEC ODOR CONTROL WOUND DRESSING | KMF | 1997-10-01 | 86 |
71 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Convatec, A Division of E.R. Squibb & Sons.
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 (15 510(k)s)
- Convatec Limited (14 510(k)s)
- Convatec, A Bristol-Myers Squibb Co. (10 510(k)s)
- Convatec, A Division of E.R. Squibb & Sons, LLC (3 510(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 Division of E.R. Squibb & Sons?
FDA lists 81 510(k) clearances under the applicant name “Convatec, A Division of E.R. Squibb & Sons” (first 1982, latest 2002), across 22 product codes in 3 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 Division of E.R. Squibb & Sons?
The median time from FDA receipt to decision across 510(k)s cleared under the name Convatec, A Division of E.R. Squibb & Sons is 73 days.
Which FDA product codes appear under Convatec, A Division of E.R. Squibb & Sons?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 13); KMF (Bandage, Liquid, 13); EXB (Collector, Ostomy, 9).
Next steps
- See all 81 Convatec, A Division of E.R. Squibb & Sons clearances with predicates and recalls
- Run predicate analysis for product code FRO, Convatec, A Division of E.R. Squibb & Sons'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.