FDA product code QNR: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
QNR is the FDA product code for blood pump for ecmo, long-term (> 6 hours) use. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under QNR, 7 in the last five years, from 5 different applicants. The average 510(k) review took 187 days (median 168); 80 days on average over the last three years. FDA has posted 2 recalls for QNR devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use |
| Device class | Class II |
| Regulation | 21 CFR 870.4100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for QNR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 186 |
| 2022 | 2 | 334 |
| 2023 | 2 | 218 |
| 2024 | 2 | 44 |
| 2025 | 1 | 117 |
Compare with all 510(k) review times · Search every QNR clearance
Top QNR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiacassist, Inc. | 3 | 2024-01-19 |
| Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | 2 | 2023-08-25 |
| Medtronic, Inc. | 1 | 2025-05-20 |
| ABBOTT MEDICAL | 1 | 2024-01-26 |
| Abbott (Formerly Thoratec Corporation) | 1 | 2022-12-08 |
Most recent QNR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250199 | Medtronic, Inc. | VitalFlow Console | 2025-05-20 | 117 |
| K234118 | ABBOTT MEDICAL | CentriMag Acute Circulatory Support System | 2024-01-26 | 29 |
| K233736 | Cardiacassist, Inc. | LifeSPARC System | 2024-01-19 | 58 |
| K223898 | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | VitalFlowTM Centrifugal Pump | 2023-08-25 | 240 |
| K230364 | Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) | VitalFlow Console | 2023-08-25 | 196 |
Recalls for QNR devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-10-10.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code QNR?
QNR is the FDA product code for blood pump for ecmo, long-term (> 6 hours) use. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel.
What device class is QNR?
Class II, regulation 21 CFR 870.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNR?
Across 8 cleared submissions the average was 187 days from receipt to decision (median 168).
Which companies have the most QNR clearances?
Cardiacassist, Inc. (3); Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) (2); Medtronic, Inc. (1); ABBOTT MEDICAL (1); Abbott (Formerly Thoratec Corporation) (1).
Have QNR devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code QNR
- Run a recall and safety report across every QNR manufacturer
- Watch product code QNR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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