Convatec, A Division of E.R. Squibb & Sons: FDA clearances and approvals
Convatec, A Division of E.R. Squibb & Sons has 84 FDA 510(k) clearances (first 1982, latest 2009), across 22 product codes in 3 review panels. Median 510(k) review time: 78 days.
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 | 16 | 16 |
| 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 |
|---|---|---|---|---|
| K090254 | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) | FRO | 2009-09-04 | 214 |
| K080383 | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING | FRO | 2008-05-02 | 80 |
| K063271 | AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING | FRO | 2007-04-16 | 168 |
| 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 |
74 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Convatec, A Division of E.R. Squibb & Sons have?
Convatec, A Division of E.R. Squibb & Sons has 84 FDA 510(k) clearances (first 1982, latest 2009), across 22 product codes in 3 review panels.
How long does FDA take to clear Convatec, A Division of E.R. Squibb & Sons's 510(k)s?
The median time from FDA receipt to decision across Convatec, A Division of E.R. Squibb & Sons's cleared 510(k)s is 78 days.
What devices does Convatec, A Division of E.R. Squibb & Sons make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 16); KMF (Bandage, Liquid, 13); EXB (Collector, Ostomy, 9).
Has Convatec, A Division of E.R. Squibb & Sons had device recalls?
openFDA lists no recalls under a recalling firm name matching Convatec, A Division of E.R. Squibb & Sons. Related entities may recall under other names.
Next steps
- See all 84 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.