Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meril Life Sciences Private Limited · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190619 | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | 2019-04-29 | 49 | 0 |
| K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx P | Meril Life Sciences Private Limited | 2018-05-17 | 30 | 0 |
| K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016-07-30 | 116 | 0 |
| K131169 | MOZEC - RX PTCA BALLOON DILATATION CATHETER | Meril Life Sciences Private Limited | 2013-12-24 | 244 | 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