QJZ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- FDA definition
- Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
- Adverse events (MAUDE)
- 2021: 52 · 2022: 53 · 2023: 104 · 2024: 75 · 2025: 131 · 2026: 73
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 Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| VitalFlow Set with Balance Biosurface (K240880) | Medtronic, Inc. | 2024-09-12 |
| Novalung ultimate kit (US) (K232926) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
| Novalung System (K191407) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 |
Track QJZ automatically
Every clearance here is in the API, with alerts when new ones post.