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

Professional Medical Services · Predicate Candidate Screening

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

72 daysmedian FDA review time

199 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K913094	DISPOSABLE SLIDE VALVE MANIFOLD	Professional Medical Services	1992-01-27	199
K910378	PRESSURE MONITORING EXTENSION LINE	Professional Medical Services	1991-04-22	83
K904508	CONDOR ANALOG INFLATION SYRINGE	Professional Medical Services	1991-04-02	180
K904954	CONDOR DIGITAL INFLATION SYRINGE	Professional Medical Services	1991-01-16	72
K902606	RADIOPAQUE RULER	Professional Medical Services	1990-09-27	107
K884577	PROCEDURE READY TRAYS	Professional Medical Services	1989-08-01	273
K890471	PMS ANGIO DRAPE	Professional Medical Services	1989-02-27	27
K884497	CONTROL SYRINGE	Professional Medical Services	1988-12-12	48
K872448	BLOOD CONTAINMENT PACK	Professional Medical Services	1987-11-17	147
K864555	3 RING ATTACHMENT	Professional Medical Services	1986-12-01	12
K854941	PMS PERCUTANEOUS PUNCTURE NEEDLE	Professional Medical Services	1986-04-16	127
K850632	PMS AMNIOCENTESIS TRAY/KIT	Professional Medical Services	1985-05-22	92
K850050	PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK	Professional Medical Services	1985-04-23	105
K844465	PMS DRAPE PACK	Professional Medical Services	1984-12-05	16
K842149	PMS SUTURE PACK/TRAY;VERTEX SUTURE	Professional Medical Services	1984-07-23	54
K841468	PMA ANGIOGRAPHY TRAY	Professional Medical Services	1984-06-05	57
K840671	CARDIAC CATHETERIZATION PACK	Professional Medical Services	1984-03-12	20
K840017	VERTEX PERCUTANEOUS CATHETER INTRODUC	Professional Medical Services	1984-02-04	31
K830637	VERTEX DIGITAL SUBSTRATION KIT	Professional Medical Services	1983-03-24	23

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