Atlas FDA

NHJ

25 FDA 510(k) clearances · Product code

164 daysmedian time to decision
300 days90th percentile
25clearances measured

FDA profile

Official device name
Device, Positive Pressure Breathing, Intermittent
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2007: 16 · 2008: 7 · 2023: 17 · 2024: 40 · 2025: 35 · 2026: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (K253001)Hunan Ruijiong Biotech Co., Ltd.2026-06-16
Clearo (K242438)Breas Medical AB2025-05-16
BiWaze Clear System (K231728)Abmrc, LLC2024-04-08
BiWaze Clear System (K213564)Abmrc, LLC2022-12-21
Maximus System (K200988)Hill-Rom Services Pte, Ltd.2020-05-26
BiWaze Cough (K191912)Abmrc, LLC2020-03-27
Maximus System (K192143)Hill-Rom Services Pte, Ltd.2020-02-14
MetaNeb 4 System (K151689)Hill-Rom Services Pte, Ltd.2016-03-17
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (K140598)Dima Italia Srl2014-10-16
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (K140605)Dima Italia Srl2014-10-03
VITAL COUGH (K132988)Lung Assist, Inc.2014-03-28
METANEB (K124032)Hill-Rom Services Pte, Ltd.2013-04-25
COMFORT COUGH (K113549)Seoil Pacific Corp.2013-02-21
COUGHASSIST T70 DEVICE (K121955)Respironics, Inc.2012-12-14
VITAL COUGH (K120277)Lung Assist, Inc.2012-09-12
NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS (K072292)Dima Italia Srl2008-01-07
POWERNEB (K051964)Comedica , Inc.2005-12-01
PERCUSSIVENEB, MODEL PN-2001 (K003684)Vortran Medical Technology 1, Inc.2001-02-23
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING (K002598)J. H. Emerson Co.2000-11-22
PIPER IPPB MODEL 2055 (K982016)Vortran Medical Technology 1, Inc.1998-11-03
PERCUSSIVETECH HF, MODEL 2001 (K981726)Vortran Medical Technology 1, Inc.1998-09-17
EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA (K924174)J. H. Emerson Co.1992-11-17
IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES (K905236)Percussionaire Corp.1991-04-18
BIRD (IPV) NONCONTINUOUS VENTILATORS (K895485)Percussionaire Corp.1989-10-30
IPPB ASSEMBLY W/NEBULIZER (K781232)Rtec1978-09-27

Track NHJ automatically

Every clearance here is in the API, with alerts when new ones post.