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

DWD — Predicate Candidate Screening

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

53 daysmedian FDA review time

193 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K992657	IBC VRV, MODEL 1350	International Biophysics Corp.	2000-02-18	193
K920077	NIKKISO NK PUMP	International Medical Products, Inc.	1993-09-29	630
K915480	B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-01-07	32
K915481	B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-01-07	32
K915482	B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-01-07	32
K905311	DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.	Baxter Bentley Laboratories, Inc.	1991-01-15	48
K895427	MEDISEAL SUCTION CANISTER	Deroyal Industries, Inc.	1990-01-19	136
K864503	MODIFIED RLV-2100 B	American Omni Medical, Inc.	1987-01-06	53
K863593	SARNS SAFETY LOOP	3M Health Care, Sarns	1986-11-18	64
K862540	LEFT VENTRICULAR VENT VALVE MODEL NO. GLV	Gish Biomedical, Inc.	1986-08-29	58
K861428	SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100	American Omni Medical, Inc.	1986-06-26	71
K851406	AJDJUSTABLE SUCTION CONTROL VALVE	American Omni Medical, Inc.	1985-08-05	118
K830149	IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-	Instrumentation Laboratory CO	1983-02-28	42
K830150	VEINPREP VEIN GRAFT PREP. KIT A277723	Atrium Medical Corp.	1983-02-28	42
K760894	VACUUM RELIEF VALVE	Delta Medical Industries	1976-12-09	44

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