Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mc3 Incorporated — 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) |
|---|---|---|---|---|---|
| K191935 | Nautilus Smart ECMO Module | Mc3 Incorporated | 2020-04-09 | 265 | 2 |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | 2018-10-29 | 11 | 0 |
| K180151 | MC3 Jugular Dual Lumen Catheter | Mc3 Incorporated | 2018-07-16 | 178 | 0 |
| K171610 | MC3 QuickFlow Dual Lumen Catheter | Mc3 Incorporated | 2017-11-16 | 168 | 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