NHJ · Class II · 21 CFR 868.5905

FDA Product Code NHJ: Device, Positive Pressure Breathing, Intermittent

Leading manufacturers include Hill-Rom Services Pte, Ltd., Abmrc, LLC and Vortran Medical Technology 1, Inc..

26
Total
26
Cleared
187d
Avg days
1978
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 241d recently vs 179d historically

FDA 510(k) Cleared Device, Positive Pressure Breathing, Intermittent Devices (Product Code NHJ)

26 devices
1–24 of 26
Cleared Aug 24, 2026
BiWaze Clear System
K260604
Abmrc, LLC
Anesthesiology · 181d
Cleared Jun 16, 2026
KT Airway Clearance Device II (KT-3)
K253001
Hunan Ruijiong Biotech Co., Ltd.
Anesthesiology · 270d
Cleared May 16, 2025
Clearo
K242438
Breas Medical AB
Anesthesiology · 273d
Cleared Apr 08, 2024
BiWaze Clear System
K231728
Abmrc, LLC
Anesthesiology · 300d
Cleared Dec 21, 2022
BiWaze Clear System
K213564
Abmrc, LLC
Anesthesiology · 407d
Cleared May 26, 2020
Maximus System
K200988
Hill-Rom Services Pte, Ltd.
Anesthesiology · 41d
Cleared Mar 27, 2020
BiWaze Cough
K191912
Abmrc, LLC
Anesthesiology · 254d
Cleared Feb 14, 2020
Maximus System
K192143
Hill-Rom Services Pte, Ltd.
Anesthesiology · 190d
Cleared Mar 17, 2016
MetaNeb 4 System
K151689
Hill-Rom Services Pte, Ltd.
Anesthesiology · 268d
Cleared Oct 16, 2014
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
K140598
Dima Italia Srl
Anesthesiology · 220d
Cleared Oct 03, 2014
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
K140605
Dima Italia Srl
Anesthesiology · 207d
Cleared Mar 28, 2014
VITAL COUGH
K132988
Lung Assist, Inc.
Anesthesiology · 185d
Cleared Apr 25, 2013
METANEB
K124032
Hill-Rom Services Pte, Ltd.
Anesthesiology · 118d
Cleared Feb 21, 2013
COMFORT COUGH
K113549
Seoil Pacific Corp.
Anesthesiology · 448d
Cleared Dec 14, 2012
COUGHASSIST T70 DEVICE
K121955
Respironics, Inc.
Anesthesiology · 164d
Cleared Sep 12, 2012
VITAL COUGH
K120277
Lung Assist, Inc.
Anesthesiology · 226d
Cleared Jan 07, 2008
NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
K072292
Dima Italia Srl
Anesthesiology · 144d
Cleared Dec 01, 2005
POWERNEB
K051964
Comedica , Inc.
Anesthesiology · 134d
Cleared Feb 23, 2001
PERCUSSIVENEB, MODEL PN-2001
K003684
Vortran Medical Technology 1, Inc.
Anesthesiology · 86d
Cleared Nov 22, 2000
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
K002598
J. H. Emerson Co.
Anesthesiology · 93d
Cleared Nov 03, 1998
PIPER IPPB MODEL 2055
K982016
Vortran Medical Technology 1, Inc.
Anesthesiology · 148d
Cleared Sep 17, 1998
PERCUSSIVETECH HF, MODEL 2001
K981726
Vortran Medical Technology 1, Inc.
Anesthesiology · 125d
Cleared Nov 17, 1992
EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA
K924174
J. H. Emerson Co.
Anesthesiology · 90d

About Product Code NHJ - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code NHJ since 1978, with 26 receiving FDA clearance (average review time: 187 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NHJ Product Code

Recent submissions under NHJ have taken an average of 241 days to reach a decision - up from 179 days historically. Manufacturers should account for longer review timelines in current project planning.

NHJ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →