Product Code: NHJ FDA class 2 21 CFR 868.5905

Device, Positive Pressure Breathing, Intermittent

Anesthesiology

The Device, Positive Pressure Breathing, Intermittent (product code NHJ) is an anesthesiology respiratory device that delivers intermittent positive pressure breaths to assist ventilation in patients with respiratory compromise, used in clinical or home settings for respiratory therapy. It is classified as an FDA Class 2 device within the Anesthesiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: NHJ
Device Class: FDA class 2
Regulation Number: 868.5905
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253001	KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)	Jun 16, 2026	Substantially Equivalent	Hunan Ruijiong Biotech Co., Ltd.
K242438	Clearo	May 16, 2025	Substantially Equivalent	Breas Medical AB
K231728	BiWaze Clear System	Apr 08, 2024	Substantially Equivalent	Abmrc, LLC
K213564	BiWaze Clear System	Dec 21, 2022	Substantially Equivalent	Abmrc, LLC
K200988	Maximus System	May 26, 2020	Substantially Equivalent	Hill-Rom Services Pte, Ltd.
K191912	BiWaze Cough	Mar 27, 2020	Substantially Equivalent	Abmrc, LLC
K192143	Maximus System	Feb 14, 2020	Substantially Equivalent	Hill-Rom Services Pte, Ltd.
K151689	MetaNeb 4 System	Mar 17, 2016	Substantially Equivalent	Hill-Rom Services Pte, Ltd.
K140598	PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC	Oct 16, 2014	Substantially Equivalent	Dima Italia Srl
K140605	MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC	Oct 03, 2014	Substantially Equivalent	Dima Italia Srl
K132988	VITAL COUGH	Mar 28, 2014	Substantially Equivalent	Lung Assist, Inc.
K124032	METANEB	Apr 25, 2013	Substantially Equivalent	Hill-Rom Services Pte, Ltd.
K113549	COMFORT COUGH	Feb 21, 2013	Substantially Equivalent	Seoil Pacific Corp.
K121955	COUGHASSIST T70 DEVICE	Dec 14, 2012	Substantially Equivalent	Respironics, Inc.
K120277	VITAL COUGH	Sep 12, 2012	Substantially Equivalent	Lung Assist, Inc.
K072292	NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS	Jan 07, 2008	Substantially Equivalent	Dima Italia Srl
K051964	POWERNEB	Dec 01, 2005	Substantially Equivalent	Comedica , Inc.
K003684	PERCUSSIVENEB, MODEL PN-2001	Feb 23, 2001	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K002598	EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING	Nov 22, 2000	Substantially Equivalent	J. H. Emerson Co.
K982016	PIPER IPPB MODEL 2055	Nov 03, 1998	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K981726	PERCUSSIVETECH HF, MODEL 2001	Sep 17, 1998	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K924174	EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA	Nov 17, 1992	Substantially Equivalent	J. H. Emerson Co.
K905236	IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES	Apr 18, 1991	Substantially Equivalent	Percussionaire Corp.
K895485	BIRD (IPV) NONCONTINUOUS VENTILATORS	Oct 30, 1989	Substantially Equivalent	Percussionaire Corp.
K781232	IPPB ASSEMBLY W/NEBULIZER	Sep 27, 1978	Substantially Equivalent	Rtec