NHJ — Device, Positive Pressure Breathing, Intermittent Class II
FDA product code NHJ covers "Device, Positive Pressure Breathing, Intermittent", a Class II medical device regulated under 21 CFR 868.5905. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHJ
- Device Class
- Class II
- Regulation Number
- 868.5905
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253001 | hunan ruijiong biotech co | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | June 16, 2026 |
| K242438 | breas medical | Clearo | May 16, 2025 |
| K231728 | abmrc | BiWaze Clear System | April 8, 2024 |
| K213564 | abmrc | BiWaze Clear System | December 21, 2022 |
| K200988 | hill-rom services pte | Maximus System | May 26, 2020 |
| K191912 | abmrc | BiWaze Cough | March 27, 2020 |
| K192143 | hill-rom services pte | Maximus System | February 14, 2020 |
| K151689 | hill-rom services pte | MetaNeb 4 System | March 17, 2016 |
| K140598 | dima italia | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | October 16, 2014 |
| K140605 | dima italia | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | October 3, 2014 |
| K132988 | lung assist | VITAL COUGH | March 28, 2014 |
| K124032 | hill-rom services pte | METANEB | April 25, 2013 |
| K113549 | seoil pacific | COMFORT COUGH | February 21, 2013 |
| K121955 | respironics | COUGHASSIST T70 DEVICE | December 14, 2012 |
| K120277 | lung assist | VITAL COUGH | September 12, 2012 |
| K072292 | dima italia | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS | January 7, 2008 |
| K051964 | comedica | POWERNEB | December 1, 2005 |
| K003684 | vortran medical technology 1 | PERCUSSIVENEB, MODEL PN-2001 | February 23, 2001 |
| K002598 | j. h. emerson | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL | November 22, 2000 |
| K982016 | vortran medical technology 1 | PIPER IPPB MODEL 2055 | November 3, 1998 |