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

Promedic, Inc. — Predicate Candidate Screening

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

89 daysmedian FDA review time

302 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K131889	EUM 100PRO	Promedic, Inc.	2014-04-23	302
K112318	CLEARPATH 24	Promedic, Inc.	2012-06-29	323
K072756	NON-IV ADAPTER FOR INFANT NG TUBE	Promedic, Inc.	2007-12-19	83
K060497	BABYAIR	Promedic, Inc.	2006-07-11	137
K060842	REVJET TURBO	Promedic, Inc.	2006-06-21	85
K052903	PEDIATRIC FEEDING TUBE	Promedic, Inc.	2005-11-09	26
K031409	URINARY CATHETERS	Promedic, Inc.	2003-06-17	43
K024190	FENESTRATED INFUSION CATHETER	Promedic, Inc.	2003-03-17	88
K023579	GAS SAMPLING LINES	Promedic, Inc.	2003-01-28	96
K020005	INFANT FEEDING TUBES	Promedic, Inc.	2002-07-16	195
K970102	FILTER	Promedic, Inc.	1997-06-24	162
K970991	DATEX ENGSTOM MANUAL RESUSCITATOR	Promedic, Inc.	1997-06-16	89
K962182	BURLEW INFANT HOOD	Promedic, Inc.	1996-07-15	39
K954201	BUONAFEDE PNEUMATIC SLEEVE	Promedic, Inc.	1995-11-09	64
K951988	PRESSURIZER	Promedic, Inc.	1995-06-14	48
K951043	AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK	Promedic, Inc.	1995-06-07	92

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