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

KQT — Predicate Candidate Screening

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

50 daysmedian FDA review time

216 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K964111	LITHOVAC SUCTION/ASPIRATION PROBE	Electro Medical Systems SA	1996-12-16	62	0
K921451	EVACUATOR, GASTRO-UROLOGY	Northgate Technologies, Inc.	1992-10-28	216	1
K921088	EVACUATOR, GASTRO-UROLOGY	Northgate Technologies, Inc.	1992-10-28	236	0
K910728	CLEANFLOW SYSTEM	Mitron Technologies, Inc.	1991-04-01	40	0
K880099	VAN-TEC BLADDER EVACUATOR	Van-Tec, Inc.	1988-03-02	50	1
K874493	BELLA - VAC IRRIGATOR	Bel-Can Industries	1988-02-05	95	0
K860266	ELLIK EVACUATOR	R. J. Ltd., Ind.	1986-03-05	37	0
K830546	DOSIMETRIC RELEASE	American Hospital Supply Corp.	1983-05-25	92	0
K811779	ROSS-EMERSON PUMP, MODEL 55-R	J. H. Emerson Co.	1981-07-13	20	0
K810739	SUCTION WOUND DRAINAGE DEVICE	The Urology Group	1981-06-26	99	0
K801781	CATHETER IRRIGATION SYRINGES, #3100,3110	The Healthcare Group Laboratories, Inc.	1980-08-13	16	0
K801782	GENERAL PURPOSE IRRIGATING/ASPIR SYR.	The Healthcare Group Laboratories, Inc.	1980-08-13	16	0
K800397	ELLIK BLADDER EVACUATOR	Sage Products, Inc.	1980-03-10	13	0
K791306	ELLIK EVACUATOR	Davol, Inc.	1979-08-03	18	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