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

JMT · Predicate Candidate Screening

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

129 daysmedian FDA review time

329 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251800	Healgen® URS Test Strips	Healgen Scientific,, LLC	2025-12-23	194	0
K252607	AllTest Urinary Tract Infection Test	Hangzhou AllTest Biotech Co., Ltd.	2025-10-30	73	0
K242767	Safecare Urinary Tract Infection Test	Safecare Biotech (Hangzhou) Co., Ltd.	2025-01-10	119	0
K170118	Scanostics UTI Check Application Test System	Teco Diagnostics	2017-09-21	251	0
K100024	TECO DIAGNOSTICS UTI DETECTION STRIPS	Teco Diagnostics	2011-02-17	408	0
K993850	URINALYSIS REAGENT STRIPS (10 PARAMETERS)	International Newtech Development, Inc.	2000-01-03	52	2
K990873	DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE	Ameritek, Inc.	1999-09-01	169	0
K954685	URITEST - NITRITE IN URINE TEST	Tcpi, Inc.	1996-07-22	285	0
K960888	CHEK-STIX U.T.I. SELF-TEST	Bayer Corp.	1996-07-05	123	0
K953672	FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS	Polymer Technology Intl.	1996-07-01	329	0
K875248	BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS	Bioscan Instruments, Inc.	1988-02-24	64	0
K855238	BIOTEL (TM)/UTI	American Diagnostic Corp.	1986-05-09	129	0
K840828	KYOTEST 8V	Kyoto Diagnostics, Inc.	1984-05-14	80	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