Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NHJ — Predicate Candidate Screening

25 FDA 510(k) clearances under this product code; the 50 most recent screened below.

164 daysmedian FDA review time

300 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253001	KT Airway Clearance Device II (KT-3); KT Airway Clearance De	Hunan Ruijiong Biotech Co., Ltd.	2026-06-16	270	0
K242438	Clearo	Breas Medical AB	2025-05-16	273	0
K231728	BiWaze Clear System	Abmrc, LLC	2024-04-08	300	0
K213564	BiWaze Clear System	Abmrc, LLC	2022-12-21	407	0
K200988	Maximus System	Hill-Rom Services Pte, Ltd.	2020-05-26	41	9
K191912	BiWaze Cough	Abmrc, LLC	2020-03-27	254	0
K192143	Maximus System	Hill-Rom Services Pte, Ltd.	2020-02-14	190	7
K151689	MetaNeb 4 System	Hill-Rom Services Pte, Ltd.	2016-03-17	268	0
K140598	PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC	Dima Italia Srl	2014-10-16	220	0
K140605	MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC	Dima Italia Srl	2014-10-03	207	0
K132988	VITAL COUGH	Lung Assist, Inc.	2014-03-28	185	0
K124032	METANEB	Hill-Rom Services Pte, Ltd.	2013-04-25	118	0
K113549	COMFORT COUGH	Seoil Pacific Corp.	2013-02-21	448	0
K121955	COUGHASSIST T70 DEVICE	Respironics, Inc.	2012-12-14	164	0
K120277	VITAL COUGH	Lung Assist, Inc.	2012-09-12	226	0
K072292	NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS	Dima Italia Srl	2008-01-07	144	0
K051964	POWERNEB	Comedica , Inc.	2005-12-01	134	0
K003684	PERCUSSIVENEB, MODEL PN-2001	Vortran Medical Technology 1, Inc.	2001-02-23	86	0
K002598	EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MO	J. H. Emerson Co.	2000-11-22	93	0
K982016	PIPER IPPB MODEL 2055	Vortran Medical Technology 1, Inc.	1998-11-03	148	0
K981726	PERCUSSIVETECH HF, MODEL 2001	Vortran Medical Technology 1, Inc.	1998-09-17	125	0
K924174	EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA	J. H. Emerson Co.	1992-11-17	90	0
K905236	IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES	Percussionaire Corp.	1991-04-18	162	1
K895485	BIRD (IPV) NONCONTINUOUS VENTILATORS	Percussionaire Corp.	1989-10-30	49	0
K781232	IPPB ASSEMBLY W/NEBULIZER	Rtec	1978-09-27	68	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda