NHJ
- Product code
- NHJ
- Device name
- Device, Positive Pressure Breathing, Intermittent
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5905
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 26 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260604 | 2026-08-24 | Abmrc, LLC | BiWaze Clear System | |
| K253001 | 2026-06-16 | Hunan Ruijiong Biotech Co., Ltd. | KT Airway Clearance Device II (KT-3); KT Airway Clea… | |
| K242438 | 2025-05-16 | Breas Medical AB | Clearo | |
| K231728 | 2024-04-08 | Abmrc, LLC | BiWaze Clear System |
Official FDA classification page: NHJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).