Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PWJ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
246 daysmedian FDA review time
281 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturat | ETHICON, Inc. | 2018-08-10 | 101 | 0 |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigi | ETHICON, Inc. | 2018-07-06 | 281 | 0 |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reu | ETHICON, Inc. | 2018-06-28 | 272 | 0 |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Cal | Caldera Medical, Inc. | 2018-05-04 | 246 | 0 |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Devic | Boston Scientific Corporation | 2017-12-20 | 117 | 0 |
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