Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

CGL · Predicate Candidate Screening

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

119 daysmedian FDA review time

453 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261039	i-STAT Crea cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2026-06-26	88	0
K171059	Nova StatSensor Creatinine Hospital Meter System	Nova Biomedical Corporation	2017-05-26	46	0
K113726	EPOC CHLORIDE TEST AND EPOC CREATININE TEST	Epocal, Inc.	2012-10-05	291	0
K070068	NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS	Nova Biomedical Corp.	2007-05-07	119	5
K051968	ABL8X7 FLEX	Radiometer Medical Aps	2006-10-16	453	3
K991727	STAT PROFILE M7 ANALYZER	Nova Biomedical Corp.	1999-07-16	57	0
K973292	I-STAT SYSTEM	I-Stat Corp.	1997-10-20	48	2
K903034	RENALYZER PRX 90	Swedish Trade Council USA	1991-03-13	245	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