NOU
7 FDA 510(k) clearances · Product code
401 daysmedian time to decision
458 days90th percentile
7clearances measured
FDA profile
- Official device name
- Continuous, Ventilator, Home Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Medical specialty
- Anesthesiology
- Flags
- Life-sustaining
- FDA definition
- This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
- Adverse events (MAUDE)
- 2021: 248 · 2022: 336 · 2023: 1,259 · 2024: 817 · 2025: 935 · 2026: 499
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 |
|---|---|---|
| Vivo 45 LS (K233452) | Breas Medical AB | 2025-01-13 |
| Vivo 45 LS (K193586) | Breas Medical AB | 2021-01-27 |
| Vivo 60 (K160481) | Breas Medical AB | 2016-11-09 |
| VIVO 50 (K123144) | Ge Healthcare, Breas Medical AB | 2013-06-18 |
| PLV CONTINUUM VENTILATOR, MODEL P2000 (K034032) | Respironics California, Inc. | 2004-03-16 |
| PLV CONTINUUM VENTILATOR, MODEL P1000 (K022750) | Respironics California, Inc. | 2003-11-20 |
| IVENT 201 PORTABLE VENTILATOR (K021981) | Versamed , Ltd. | 2003-08-13 |
Track NOU automatically
Every clearance here is in the API, with alerts when new ones post.