Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYS · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232767 | Nautilus VF ECMO Oxygenator | Mc3, Inc. | 2023-10-04 | 23 | 0 |
| K191935 | Nautilus Smart ECMO Module | Mc3 Incorporated | 2020-04-09 | 265 | 2 |
| K770720 | TUBING PACK, EXTRACORPOREAL, H-3000 | William Harvey Life Products Corp. | 1977-08-04 | 108 | 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