Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Convatec Limited — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
268 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Cathet | Convatec Limited | 2026-04-01 | 198 | 0 |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Ki | Convatec Limited | 2025-06-06 | 73 | 0 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Cath | Convatec Limited | 2022-06-22 | 264 | 0 |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit | Convatec Limited | 2019-04-30 | 96 | 0 |
| K180205 | AVELLE Negative Pressure Wound Therapy System | Convatec Limited | 2018-10-19 | 268 | 0 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018-08-16 | 101 | 0 |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver a | Convatec Limited | 2018-07-20 | 232 | 0 |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017-11-21 | 57 | 0 |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016-09-20 | 130 | 0 |
| K152926 | AQUACEL Ag Surgical SP Dressing | Convatec Limited | 2016-01-21 | 108 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda