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

FEG — Predicate Candidate Screening

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

87 daysmedian FDA review time

417 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171619	14Fr Colon Decompression Set, Macon Colon Decompression Set	Cook Ireland, Ltd.	2017-08-01	60	0
K132314	MEDLINE ANTI-REFLUX VALVE	Medline Industries, Inc.	2013-09-18	55	0
K053410	GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR	Kendall	2006-01-06	30	0
K040388	NEXT GENERATION SALEM SUMP	Kendall	2004-05-17	90	0
K971354	KNOTT NG TUBE	Michael M. Knott, M.D.	1997-11-19	222	0
K960176	DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER	C.R. Bard, Inc.	1996-07-24	190	17
K926073	ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE	Surgimark, Inc.	1995-05-15	895	0
K935781	ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY	Sherwood Medical Co.	1995-01-27	417	0
K921104	LOPEZ VALVE WITH NG SUMP TUBE	Icu Medical, Inc.	1992-10-26	231	0
K900035	WILSON-COOK COLON DECOMPRESSION SET	Wilson-Cook Medical, Inc.	1990-03-07	64	2
K880850	KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE	Kmb Medical Products Co.	1988-05-26	86	2
K772282	HODGE TUBE	Mallinckrodt Critical Care	1978-03-09	87	0
K771048	CATHETERS, DRAINAGE	Axiom Medical, Inc.	1977-07-19	39	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