Convatec Limited: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Convatec Limited” (first 2016, latest 2026), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 119 days. Since 2017 the median was 150 days, against 205 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 2 | 119 |
| 2017 | 1 | 57 |
| 2018 | 3 | 232 |
| 2019 | 1 | 96 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 264 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 73 |
| 2026 | 1 | 198 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Convatec Limited took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 205 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 2 | 2 |
| GBM | Catheter, Urethral | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| EZD | Catheter, Straight | 1 | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 1 | 1 |
Review panels
Most recent Convatec Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | EZD | 2026-04-01 | 198 |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | FCM | 2025-06-06 | 73 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | GBM | 2022-06-22 | 264 |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | 2019-04-30 | 96 |
| K180205 | AVELLE Negative Pressure Wound Therapy System | OMP | 2018-10-19 | 268 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | GBM | 2018-08-16 | 101 |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | FRO | 2018-07-20 | 232 |
| K172924 | GentleCath Intermittent Urinary Catheter | KOD | 2017-11-21 | 57 |
| K161344 | GentleCath Glide Intermittent Catheter | KOD | 2016-09-20 | 130 |
| K152926 | AQUACEL Ag Surgical SP Dressing | FRO | 2016-01-21 | 108 |
Recalls
openFDA lists no recalls under a recalling firm named Convatec Limited.
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, A Bristol-Myers Squibb Co. (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 Limited?
FDA lists 10 510(k) clearances under the applicant name “Convatec Limited” (first 2016, latest 2026), across 7 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 Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Convatec Limited is 119 days. Since 2017: 150 days, versus 205 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Convatec Limited?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 2); GBM (Catheter, Urethral, 2); KOD (Catheter, Urological, 2).
Next steps
- See all 10 Convatec Limited clearances with predicates and recalls
- Run predicate analysis for product code FRO, Convatec Limited'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.