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

BYT — Predicate Candidate Screening

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

81 daysmedian FDA review time

147 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K082657	RTX RESPIRATOR	Medivent Limited	2008-10-08	26
K072290	PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS	Dima Italia Srl	2008-05-29	287
K924341	HAYEK OSCILLATOR(TM)	Respironics, Inc.	1993-07-21	328
K910947	NEV-10 NEGATIVE PRESSURE VENTILATOR	Lifecare Services, Inc.	1991-06-03	89
K905530	PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM	Puritan Bennett Corp.	1991-03-01	81
K902764	EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM	J. H. Emerson Co.	1990-11-19	147
K903745	THE HAYEK OSCILLATOR	Flexco Medical Instruments	1990-11-09	85
K902300	EASY BREATHER MODEL 100 ACCESSORIES	Progressive Productions , Ltd.	1990-07-19	57
K895849	RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM	Respironics, Inc.	1989-12-22	80
K894649	EMERSON 33-CR CHEST RESPIRATOR	Emerson Intl. Co.	1989-10-13	81
K893213	EASY BREATHER MODEL 100	Progressive Productions , Ltd.	1989-08-04	99
K881808	EMERSON CHEST RESPIRATOR, MODEL 33-CRE	J. H. Emerson Co.	1988-08-04	98
K881689	LINDLEY II RESUSCITATOR	Lindley Resuscitator, Inc.	1988-07-08	80
K863300	Q101 DIAGNOSTIC SPIROMETER	Quinton, Inc.	1986-11-13	80
K860692	PTR MK II VENTILATOR	Bear Medical Systems, Inc.	1986-05-21	85
K840885	LAKEVILLE BODY VENTILATOR	Edwards Ventilator Co.	1984-07-12	136
K841090	VENTILATOR EXTERNAL BODY NEGATIVE PRESS	Porta-Lung Co.	1984-05-30	78
K832176	NEGATIVE PRESSURE CHEST RESPIRATOR PUMP	J. H. Emerson Co.	1983-09-12	68
K813326	TROCKI BODY VENTRILATOR	L.T.D. 3 Co.	1981-12-22	28
K792673	CAM-10 CUIRASS SHELL	Lifecare Services, Inc.	1980-01-11	15
K791406	CAM-10 CHEST SHELL	Lifecare Services, Inc.	1979-08-10	10

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