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

KRK — Predicate Candidate Screening

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

47 daysmedian FDA review time

218 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K950607	UST-5268P-5 TRANSDUCER	Aloka Co., Ltd.	1995-09-15	218	0
K904674	CENTRAL VENOUS PRESSURE MANOMETER	Medex, Inc.	1990-12-27	76	1
K884386	ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK	Ethitek Pharmaceuticals Co.	1989-01-05	79	0
K875322	MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER	Schneider-Shilley (Usa)	1988-03-28	90	0
K861605	SCHNEIDER-SHILEY PRESSURE MANOMETER	Shiley, Inc.	1986-05-28	29	0
K830910	MANOMETER SET C.V.P. #S 298/299	Exco, Inc.	1983-04-05	15	0
K813498	MEDIFIX	Burron Medical Products, Inc.	1982-01-07	24	0
K813195	MEDIFIX GRADUATED SCALE	Burron Medical Products, Inc.	1981-12-29	47	0
K790668	VENOUS PRESSURE MONITOR, MF 35 LF	Deco Medical, Inc.	1979-05-23	47	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