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

Medline — Predicate Candidate Screening

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

56 daysmedian FDA review time

335 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K120156	PUREIMAGE ULTRASOUND TRANSMISSION GEL	Medline	2012-02-08	21
K051378	POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE	Medline	2005-08-03	69
K010825	MEDLINE STERISET STERILIZATION CONTAINER	Medline	2001-05-08	50
K990463	MEDLINE EXCEL WHEELCHAIRS	Medline	1999-03-15	31
K970282	MEDLINE CIRCUMCISION TRAY	Medline	1997-03-06	41
K963504	MEDLINE OPEN END FINGER CONTROL MITT	Medline	1996-10-29	56
K963452	MEDLINE ZIPPER SLEEVED VEST	Medline	1996-10-18	45
K951736	LOCK-UP	Medline	1995-07-05	83
K932033	LAPAROSCOPIC SURGERY INSTRUMENTS	Medline	1995-06-19	783
K932060	MARTIN COLD LIGHT FOUNTAIN	Medline	1994-03-30	335
K915502	MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES	Medline	1992-04-29	142

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