Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QNR — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
186 daysmedian FDA review time
519 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250199 | VitalFlow Console | Medtronic, Inc. | 2025-05-20 | 117 | 1 |
| K234118 | CentriMag™ Acute Circulatory Support System | ABBOTT MEDICAL | 2024-01-26 | 29 | 0 |
| K233736 | LifeSPARC System | Cardiacassist, Inc. | 2024-01-19 | 58 | 0 |
| K230364 | VitalFlow™ Console | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 | 196 | 1 |
| K223898 | VitalFlowTM Centrifugal Pump | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 | 240 | 0 |
| K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulat | Abbott (Formerly Thoratec Corporation) | 2022-12-08 | 150 | 1 |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | 2022-11-15 | 519 | 0 |
| K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | 2021-03-26 | 186 | 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