Product code NHJ
- Device name
- Device, Positive Pressure Breathing, Intermittent
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5905
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242438 | Clearo | Breas Medical AB | 2025-05-16 |
| K231728 | BiWaze Clear System | Abmrc, LLC | 2024-04-08 |
| K213564 | BiWaze Clear System | Abmrc, LLC | 2022-12-21 |
| K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020-05-26 |
| K191912 | BiWaze Cough | Abmrc, LLC | 2020-03-27 |
| K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020-02-14 |
| K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016-03-17 |
| K140598 | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | Dima Italia Srl | 2014-10-16 |
| K140605 | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | Dima Italia Srl | 2014-10-03 |
| K132988 | VITAL COUGH | Lung Assist, Inc. | 2014-03-28 |
| K124032 | METANEB | Hill-Rom Services Pte, Ltd. | 2013-04-25 |
| K113549 | COMFORT COUGH | Seoil Pacific Corp. | 2013-02-21 |
| K121955 | COUGHASSIST T70 DEVICE | Respironics, Inc. | 2012-12-14 |
| K120277 | VITAL COUGH | Lung Assist, Inc. | 2012-09-12 |
| K072292 | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS | Dima Italia Srl | 2008-01-07 |
| K051964 | POWERNEB | Comedica , Inc. | 2005-12-01 |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | Vortran Medical Technology 1, Inc. | 2001-02-23 |
| K002598 | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING | J. H. Emerson Co. | 2000-11-22 |
| K982016 | PIPER IPPB MODEL 2055 | Vortran Medical Technology 1, Inc. | 1998-11-03 |
| K981726 | PERCUSSIVETECH HF, MODEL 2001 | Vortran Medical Technology 1, Inc. | 1998-09-17 |
| K924174 | EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA | J. H. Emerson Co. | 1992-11-17 |
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES | Percussionaire Corp. | 1991-04-18 |
| K895485 | BIRD (IPV) NONCONTINUOUS VENTILATORS | Percussionaire Corp. | 1989-10-30 |
| K781232 | IPPB ASSEMBLY W/NEBULIZER | Rtec | 1978-09-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08500501360235 | BiWaze Clear Dual Lumen Circuit - Acute | Abmrc LLC | 2026-05-20 |
| 08500501360228 | BiWaze Clear Dual Lumen Circuit With Face Mask - Infant | Abmrc LLC | 2026-05-20 |
| 00849436000686 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2023-10-31 |
| B965BK181 | BiWaze Clear System | Abmrc LLC | 2023-04-14 |
| B9652037351818201130 | BiWaze Cough | Abmrc LLC | 2023-01-02 |
| 00849436000655 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2021-06-10 |
| 00849436000648 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2021-01-04 |
| 00606959058477 | CoughAssist | Respironics, Inc. | 2020-09-23 |
| 00849436000631 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2020-09-08 |
| 00849436000624 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2020-05-22 |
| 00849436000587 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2019-01-17 |
| 00849436000570 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2019-01-11 |
| 00849436000563 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2018-12-03 |
| 00849436000532 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2018-12-03 |
| 00849436000501 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2018-12-03 |
| 00849436000525 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2018-12-03 |
| 00849436000549 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2018-09-20 |
| 10637320080404 | VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2017-11-02 |
| 10637320080305 | VORTRAN PercussiveNEB 2.0 | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2017-11-02 |
| 00849436000242 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2017-06-13 |
| 00849436000341 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2017-06-13 |
| 00849436000167 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2016-09-27 |
| 00606959037434 | CoughAssist | Respironics, Inc. | 2016-09-23 |
| 10637320040224 | VORTRAN-IPPB with Manomter | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-06-14 |
| 10637320040200 | VORTRAN-IPPB | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-06-14 |
| 10637320040309 | VORTRAN PercussiveNEB | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-06-14 |
| 10637320040217 | VORTRAN-IPPB with Water Trap | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2016-06-14 |
| 00606959028630 | DirectView | Respironics, Inc. | 2016-02-16 |
| 00849436000327 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2015-10-21 |
| 00849436000273 | Percussionaire | PERCUSSIONAIRE CORPORATION | 2015-10-21 |