Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MWS — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041338 | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES | Medtronic Vascular | 2004-07-19 | 60 | 0 |
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Pilling Weck Surgical | 2000-09-13 | 415 | 0 |
| K992833 | VACUUM ASSIST STABILIZER | Cardio Thoracic Systems | 1999-11-10 | 79 | 0 |
| K982419 | HEART-LIFT BALLOON POSITIONER | Cardiothoracic Systems, Inc. | 1999-01-13 | 184 | 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