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

FGM · Predicate Candidate Screening

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

122 daysmedian FDA review time

161 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K041732	CAVERMAP SURGICAL AID	Blue Torch Medical Technologies	2004-09-21	88	0
K031527	MODIFICATION TO CAVERMAP SURGICAL AID	Blue Torch Medical Technologies	2003-06-05	21	0
K010098	MODIFICATION TO CAVERMAP SURGICAL AID	Uromed Corp.	2001-02-01	21	0
K993436	CAVERMAP SURGICAL AID	Uromed Corp.	2000-02-11	122	1
K944379	ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG	Regulatory & Marketing Services, Inc.	1995-02-15	161	0
K944378	ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG	Regulatory & Marketing Services, Inc.	1995-02-15	161	0
K944384	ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG	Regulatory & Marketing Services, Inc.	1995-02-15	161	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