FDA Product Code
FDA Product Code NHJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5905
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260604 | BiWaze Clear System | Abmrc, LLC | 2026-08-24 | Traditional | PDF ↗ |
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | 2026-06-16 | Traditional | PDF ↗ |
| K242438 | Clearo | Breas Medical AB | 2025-05-16 | Traditional | PDF ↗ |
| K231728 | BiWaze Clear System | Abmrc, LLC | 2024-04-08 | Traditional | PDF ↗ |
| K213564 | BiWaze Clear System | Abmrc, LLC | 2022-12-21 | Traditional | PDF ↗ |
| K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020-05-26 | Special | PDF ↗ |
| K191912 | BiWaze Cough | Abmrc, LLC | 2020-03-27 | Traditional | PDF ↗ |
| K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020-02-14 | Traditional | PDF ↗ |
| K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016-03-17 | Traditional | PDF ↗ |
| K140598 | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | Dima Italia Srl | 2014-10-16 | Traditional | PDF ↗ |
| K140605 | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | Dima Italia Srl | 2014-10-03 | Traditional | PDF ↗ |
| K132988 | VITAL COUGH | Lung Assist, Inc. | 2014-03-28 | Traditional | PDF ↗ |
| K124032 | METANEB | Hill-Rom Services Pte, Ltd. | 2013-04-25 | Traditional | PDF ↗ |
| K113549 | COMFORT COUGH | Seoil Pacific Corp. | 2013-02-21 | Traditional | PDF ↗ |
| K121955 | COUGHASSIST T70 DEVICE | Respironics, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K120277 | VITAL COUGH | Lung Assist, Inc. | 2012-09-12 | Traditional | PDF ↗ |
| K072292 | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS | Dima Italia Srl | 2008-01-07 | Traditional | PDF ↗ |
| K051964 | POWERNEB | Comedica , Inc. | 2005-12-01 | Traditional | PDF ↗ |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | Vortran Medical Technology 1, Inc. | 2001-02-23 | Special | PDF ↗ |
| K002598 | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING | J. H. Emerson Co. | 2000-11-22 | Special | PDF ↗ |
| K982016 | PIPER IPPB MODEL 2055 | Vortran Medical Technology 1, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K981726 | PERCUSSIVETECH HF, MODEL 2001 | Vortran Medical Technology 1, Inc. | 1998-09-17 | Traditional | PDF ↗ |
| K924174 | EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA | J. H. Emerson Co. | 1992-11-17 | Traditional | PDF ↗ |
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | Percussionaire Corp. | 1991-04-18 | Traditional | PDF ↗ |
| K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS | Percussionaire Corp. | 1989-10-30 | Traditional | PDF ↗ |
| K781232 | IPPB ASSEMBLY W/NEBULIZER | Rtec | 1978-09-27 | Traditional | PDF ↗ |
Product code NHJ · Class II · Anesthesiology. Data: openFDA.