NHJ · Device, Positive Pressure Breathing, Intermittent
Anesthesiology · 21 CFR 868.5905 · Class 2
Overview
| Product Code | NHJ |
|---|---|
| Device Name | Device, Positive Pressure Breathing, Intermittent |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242438 | Clearo | Breas Medical AB | May 16, 2025 | SESE |
| K231728 | BiWaze Clear System | Abmrc, LLC | Apr 8, 2024 | SESE |
| K213564 | BiWaze Clear System | Abmrc, LLC | Dec 21, 2022 | SESE |
| K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | May 26, 2020 | SESE |
| K191912 | BiWaze Cough | Abmrc, LLC | Mar 27, 2020 | SESE |
| K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | Feb 14, 2020 | SESE |
| K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | Mar 17, 2016 | SESE |
| K140598 | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | Dima Italia Srl | Oct 16, 2014 | SESE |
| K140605 | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | Dima Italia Srl | Oct 3, 2014 | SESE |
| K132988 | VITAL COUGH | Lung Assist, Inc. | Mar 28, 2014 | SESE |
| K124032 | METANEB | Hill-Rom Services Pte, Ltd. | Apr 25, 2013 | SESE |
| K113549 | COMFORT COUGH | Seoil Pacific Corp. | Feb 21, 2013 | SESE |
| K121955 | COUGHASSIST T70 DEVICE | Respironics, Inc. | Dec 14, 2012 | SESE |
| K120277 | VITAL COUGH | Lung Assist, Inc. | Sep 12, 2012 | SESE |
| K072292 | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS | Dima Italia Srl | Jan 7, 2008 | SESE |
| K051964 | POWERNEB | Comedica , Inc. | Dec 1, 2005 | SESE |
| K003684 | PERCUSSIVENEB, MODEL PN-2001 | Vortran Medical Technology 1, Inc. | Feb 23, 2001 | SESE |
| K002598 | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING | J. H. Emerson Co. | Nov 22, 2000 | SESE |
| K982016 | PIPER IPPB MODEL 2055 | Vortran Medical Technology 1, Inc. | Nov 3, 1998 | SESE |
| K981726 | PERCUSSIVETECH HF, MODEL 2001 | Vortran Medical Technology 1, Inc. | Sep 17, 1998 | SESE |
Top Applicants
- Hill-Rom Services Pte, Ltd. — 4 clearances
- Abmrc, LLC — 3 clearances
- Dima Italia Srl — 3 clearances
- Vortran Medical Technology 1, Inc. — 3 clearances
- J. H. Emerson Co. — 2 clearances
