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

JIO — Predicate Candidate Screening

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

162 daysmedian FDA review time

279 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232317	UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent St	Urit Medical Electronic Co., Ltd.	2024-04-26	267	0
K111999	HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT	Healgen Scientific,, LLC	2012-04-17	279	1
K111221	MISSION U500 URINE ANALYZER	ACON Laboratories, Inc.	2012-01-18	261	0
K082811	URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND UR	Urit Medical Electronic Co., Ltd.	2009-09-11	352	0
K083724	WIENER LAB. URINE STRIP 10 AND 11	Wiener Laboratorios Saic	2009-09-02	261	0
K040703	URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS	Dirui Industrial Co., Ltd.	2004-08-26	162	0
K023297	URS-1B (BLOOD TEST)	Teco Diagnostics	2003-03-06	155	0
K921495	DIA STRIPS SYSTEM, MODIFIED	Symcon Intl., Inc.	1992-07-21	137	0
K913005	BACTIDROP(TM) LACTOPHENOL ANILINE BLUE	Remel Co.	1991-09-16	70	0
K905396	HEMASTIX REAGENT STRIPS	Heraeus Kulzer, Inc.	1991-02-11	73	0
K893894	CHARISE CHARLES REAGENT BLOOD STRIPS	Lee Import Domestic Consulting	1989-07-27	58	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