Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Engineered Medical Systems — Predicate Candidate Screening

22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

123 daysmedian FDA review time

217 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023683	MULTI-STRAP FULL FACE MASK	Engineered Medical Systems	2003-12-01	395	0
K013728	TRACH VOX	Engineered Medical Systems	2002-07-30	263	0
K013122	EMS ELECTROSTATIC FLITER AND HME COMBINATION	Engineered Medical Systems	2002-04-19	212	0
K013089	EMS HEPA FILTER AND HME COMBINATIONS	Engineered Medical Systems	2002-03-14	178	0
K013123	EMS PULMONARY FUNCTION TESTING FILTER	Engineered Medical Systems	2002-03-14	176	0
K003497	DISPOSABLE PRESSURE MONITOR	Engineered Medical Systems	2000-11-30	17	0
K000215	SWIVEL ELBOW	Engineered Medical Systems	2000-05-26	123	0
K000314	INCENTIVE SPIROMETER	Engineered Medical Systems	2000-04-12	71	0
K991955	MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL	Engineered Medical Systems	1999-07-06	35	0
K991953	MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL	Engineered Medical Systems	1999-07-01	30	0
K983919	EMS MOUTH TO MASK RESUSCITATORS	Engineered Medical Systems	1999-04-07	154	0
K983920	EMS PEEP VALVES- ADJUSTABLE	Engineered Medical Systems	1999-01-22	79	0
K972605	EMS NASAL CPAP MASK	Engineered Medical Systems	1998-01-28	201	0
K932799	SINGLE USE MANUAL RESUSCITATOR PEEP VALVE	Engineered Medical Systems	1993-09-03	86	0
K932797	PRESSURE LIMITING ELBOW	Engineered Medical Systems	1993-09-03	86	0
K924671	BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT	Engineered Medical Systems	1993-04-21	217	0
K930083	EMS BIOPSY INSTRUMENT	Engineered Medical Systems	1993-04-21	104	0
K924610	BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT	Engineered Medical Systems	1993-04-06	207	1
K912203	EMS SINGLE USE MANUAL RESUSCITATORS	Engineered Medical Systems	1991-11-13	177	0
K913014	EMS PERCUSSOR	Engineered Medical Systems	1991-10-23	107	0
K874746	SEALFLEX MASK	Engineered Medical Systems	1987-12-21	33	1
K871851	RIBBED CUSHION MASK	Engineered Medical Systems	1987-06-08	27	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