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

Arkray, Inc. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

175 daysmedian FDA review time

788 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232416	AUTION EYE AI-4510 Urine Particle Analysis System	Arkray, Inc.	2024-05-03	266	0
K193514	AUTION MAX AX-4060 Urinalysis System	Arkray, Inc.	2023-04-13	1211	0
K221175	Multi-Lancet Device 2, ReliOn Premier Lancing Device	Arkray, Inc.	2022-10-17	175	0
K200788	Assure Titanium Blood Glucose Monitoring System	Arkray, Inc.	2022-05-23	788	0
K160062	AUTION ELEVEN Semi-Automated Urinalysis System	Arkray, Inc.	2016-10-07	269	0
K121456	AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALY	Arkray, Inc.	2013-02-01	261	0
K093098	AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM	Arkray, Inc.	2009-12-23	83	0
K053401	SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS	Arkray, Inc.	2006-03-24	108	1
K051648	SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS	Arkray, Inc.	2006-01-31	224	0
K051432	SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS	Arkray, Inc.	2005-06-17	16	0
K050790	SPOTCHEM II LDH TEST	Arkray, Inc.	2005-06-06	70	0
K050652	SPOTCHEM II CREATININE, AMYLASE & ALP TESTS	Arkray, Inc.	2005-04-06	23	0
K050077	SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TEST	Arkray, Inc.	2005-02-15	34	0
K042443	SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TES	Arkray, Inc.	2004-11-24	76	0
K041427	THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TEST	Arkray, Inc.	2004-11-24	180	1
K040332	POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER	Arkray, Inc.	2004-06-16	127	0
K030553	ARKIT HBA1C	Arkray, Inc.	2003-09-02	193	0
K022386	POCKETCHEM UA AUTION STICKS 10TA	Arkray, Inc.	2002-09-17	57	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