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

KRL — Predicate Candidate Screening

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

83 daysmedian FDA review time

203 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K103469	STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05	Sorin Group Deutschland GmbH	2011-01-18	55
K090698	CAPIOX BUBBLE TRAP WITH X-COATING	Terumo Cardiovascular Systems	2009-06-08	83
K071231	EDAC QUANTIFIER	Luna Innovations, Inc.	2007-05-17	14
K961364	AUTOMATIC TUBING CLAMP SYSTEM (ATC)	Rocky Mountain Research, Inc.	1996-10-31	205
K961598	ELS AUTOMATIC TUBING CLAMP SYSTEM	Rocky Mountain Research, Inc.	1996-10-29	203
K940651	SARNS ULTRASONIC AIR SENSOR	3M Health Care, Sarns	1994-05-24	98
K935977	SARNS AIR DETECTION SYSTEM	3M Health Care, Sarns	1994-02-04	53
K925661	STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE	Sorin Biomedica, Fiat, USA, Inc.	1993-05-18	189
K925541	STOCKERT 1/4 BUBBLE SENSOR	Sorin Biomedica, Fiat, USA, Inc.	1993-02-02	91
K911632	CAPIOX(R) BUBBLE TRAP	Terumo Medical Corp.	1991-07-09	89
K864619	CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR	Shiley, Inc.	1987-02-03	71
K861860	COBE ACCESSORY INTERFACE MODULE (AIM)	Cobe Laboratories, Inc.	1986-07-18	65
K842054	COBE AEPS	Cobe Laboratories, Inc.	1984-08-02	72
K803102	ARTERIAL BUBBLE TRAP K-20	Delta Medical Industries	1980-12-22	13

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