Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

EXF — Predicate Candidate Screening

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

69 daysmedian FDA review time

296 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K003078	MERIT DRAINAGE DEPOT	Merit Medical Systems, Inc.	2000-12-11	69	0
K990428	DRAINAGE BAG	Remington Medical, Inc.	1999-08-12	182	2
K980005	MANAN D BAG	Medical Device Technologies, Inc.	1998-01-30	28	0
K961986	MANAN D BAG	Manan Medical Products, Inc.	1997-03-13	296	0
K963849	MANAN D BAG	Manan Medical Products, Inc.	1996-12-13	79	0
K943663	NAVARRE 600 ML DRAINAGE BAG	Navarre Biomedical , Ltd.	1994-09-08	42	0
K911129	MMG BILE BAG	Medical Technologies of Georgia	1991-08-07	146	0
K903449	URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET	Uresil Corp.	1990-09-12	44	0
K901844	URESIL TRU-CLOSE DRAINAGE BAG	Uresil Corp.	1990-06-01	38	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