Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5905](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5905) → NHJ — Device, Positive Pressure Breathing, Intermittent # NHJ · Device, Positive Pressure Breathing, Intermittent _Anesthesiology · 21 CFR 868.5905 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ ## Overview - **Product Code:** NHJ - **Device Name:** Device, Positive Pressure Breathing, Intermittent - **Regulation:** [21 CFR 868.5905](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5905) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K242438.md) | Clearo | Breas Medical AB | May 16, 2025 | SESE | | [K231728](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K231728.md) | BiWaze Clear System | Abmrc, LLC | Apr 8, 2024 | SESE | | [K213564](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K213564.md) | BiWaze Clear System | Abmrc, LLC | Dec 21, 2022 | SESE | | [K200988](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K200988.md) | Maximus System | Hill-Rom Services Pte, Ltd. | May 26, 2020 | SESE | | [K191912](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K191912.md) | BiWaze Cough | Abmrc, LLC | Mar 27, 2020 | SESE | | [K192143](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K192143.md) | Maximus System | Hill-Rom Services Pte, Ltd. | Feb 14, 2020 | SESE | | [K151689](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K151689.md) | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | Mar 17, 2016 | SESE | | [K140598](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K140598.md) | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | Dima Italia Srl | Oct 16, 2014 | SESE | | [K140605](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K140605.md) | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | Dima Italia Srl | Oct 3, 2014 | SESE | | [K132988](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K132988.md) | VITAL COUGH | Lung Assist, Inc. | Mar 28, 2014 | SESE | | [K124032](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K124032.md) | METANEB | Hill-Rom Services Pte, Ltd. | Apr 25, 2013 | SESE | | [K113549](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K113549.md) | COMFORT COUGH | Seoil Pacific Corp. | Feb 21, 2013 | SESE | | [K121955](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K121955.md) | COUGHASSIST T70 DEVICE | Respironics, Inc. | Dec 14, 2012 | SESE | | [K120277](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K120277.md) | VITAL COUGH | Lung Assist, Inc. | Sep 12, 2012 | SESE | | [K072292](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K072292.md) | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS | Dima Italia Srl | Jan 7, 2008 | SESE | | [K051964](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K051964.md) | POWERNEB | Comedica , Inc. | Dec 1, 2005 | SESE | | [K003684](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K003684.md) | PERCUSSIVENEB, MODEL PN-2001 | Vortran Medical Technology 1, Inc. | Feb 23, 2001 | SESE | | [K002598](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K002598.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K982016.md) | PIPER IPPB MODEL 2055 | Vortran Medical Technology 1, Inc. | Nov 3, 1998 | SESE | | [K981726](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ/K981726.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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