DeviceClearance

Product code QNR— Cardiovascular

LifeSPARC System

Classification name
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Total cleared
8
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QNR under 21 CFR 870.4100, via openFDA

Market context for product code QNR

FDA has cleared 8 devices under product code QNR between 2021 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNR

Adverse events under product code QNR

product code QNR
Death
11
Total
11

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QNR

Data sourced from openFDA. This site is unofficial and independent of the FDA.