QNR
8 FDA 510(k) clearances · Product code
186 daysmedian time to decision
519 days90th percentile
8clearances measured
FDA profile
- Official device name
- Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- FDA definition
- A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
- Adverse events (MAUDE)
- 2024: 134 · 2025: 188 · 2026: 58
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VitalFlow Console (K250199) | Medtronic, Inc. | 2025-05-20 |
| CentriMag™ Acute Circulatory Support System (K234118) | ABBOTT MEDICAL | 2024-01-26 |
| LifeSPARC System (K233736) | Cardiacassist, Inc. | 2024-01-19 |
| VitalFlow™ Console (K230364) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| VitalFlowTM Centrifugal Pump (K223898) | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2023-08-25 |
| CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038) | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| LifeSPARC System (K211830) | Cardiacassist, Inc. | 2022-11-15 |
| TandemHeart Pump and Escort Controller (K202751) | Cardiacassist, Inc. | 2021-03-26 |
Track QNR automatically
Every clearance here is in the API, with alerts when new ones post.