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

CEN · Predicate Candidate Screening

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

91 daysmedian FDA review time

179 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K091287	VS-SENSE TEST	Common Sense , Ltd.	2009-08-31	122
K071100	AMNISCREEN HOME DETECTION LINER KIT	Common Sense , Ltd.	2007-10-15	179
K051727	AIMSTICK URINE REAGENT STRIPS	Germaine Laboratories, Inc.	2005-10-26	120
K040008	QUICKVUE ADVANCE PH AND AMINES GLL TEST	Quidel Corp.	2004-04-29	118
K030650	STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONT	Uridynamics, Inc.	2003-04-14	45
K962718	FEMEXAM TESTCARD	Litmus Concepts, Inc.	1997-02-07	210
K840827	KYOTEST 5V	Kyoto Diagnostics, Inc.	1984-05-14	80
K830824	URINE SCREENING KIT	Syn-Kit, Inc.	1983-06-12	89
K830979	HELENA BIOSTRIP PH	Helena Laboratories	1983-05-05	37
K830091	LITH A TEST TM	Lenal Creative Approaches, Inc.	1983-02-15	35
K822241	FOLATE/B12 DUO-BEAD RADIOASSAY	Abbott Laboratories	1982-10-26	91

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