Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thrombolex, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
276 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovas | Thrombolex, Inc. | 2023-07-03 | 27 | 0 |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endov | Thrombolex, Inc. | 2023-04-20 | 276 | 0 |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 End | Thrombolex, Inc. | 2021-06-10 | 62 | 0 |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019-12-17 | 43 | 0 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2019-10-18 | 28 | 0 |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovasc | Thrombolex, Inc. | 2019-02-25 | 91 | 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