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

EYN — Predicate Candidate Screening

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

94 daysmedian FDA review time

316 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K944882	IRRIGATION TRAY	Clinical Resources, Inc.	1995-01-12	101
K923941	IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE	American Healthcare Corp.	1993-06-17	316
K923939	IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER	American Healthcare Corp.	1993-06-17	316
K923938	IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER	American Healthcare Corp.	1993-06-17	316
K923940	IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE	American Healthcare Corp.	1993-06-17	316
K900148	KIT PAK IRRIGATION TRAY	Kit Pak, Inc.	1990-04-23	102
K900737	PISTON IRRIGATION TRAY	Orion Life Systems, Inc.	1990-04-19	62
K900736	BULB IRRIGATION TRAY	Orion Life Systems, Inc.	1990-04-17	60
K801783	CATHETER IRRIGATION TRAYS, #3300, 3310 &	The Healthcare Group Laboratories, Inc.	1980-08-13	16
K792082	GAVAGE FEEDING SET	Medical Devices, Inc.	1979-11-13	28
K791020	FLUID ADMINISTRATION SET FA-3160	Burron Medical Products, Inc.	1979-06-27	26
K790607	GREENLINE IRRIGATION TRAYS	Snyder Laboratories, Inc.	1979-05-11	43
K781918	IRRIGATOR, BODY CAVITY	Bci, Inc.	1979-02-15	94
K781748	IRRIGATION TRAY	Intermed, Inc.	1978-12-12	56
K760047	TRAY, BLADDER IRRIGATION	M-C Ind., Inc.	1977-03-01	259

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