Atlas FDA

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

Arkray Factory USA, Inc. · Predicate Candidate Screening

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

185 daysmedian FDA review time
231 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110709ARK CARE DIABETES MANAGMENT SYSTEMArkray Factory USA, Inc.2011-05-19660
K093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)Arkray Factory USA, Inc.2010-06-091770
K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMArkray Factory USA, Inc.2009-11-241330
K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORINGArkray Factory USA, Inc.2009-10-231900
K090653POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEMArkray Factory USA, Inc.2009-10-092120
K090332ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001Arkray Factory USA, Inc.2009-08-141850
K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 731Arkray Factory USA, Inc.2008-10-21600
K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEMArkray Factory USA, Inc.2008-06-131930
K063771GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEMArkray Factory USA, Inc.2007-08-092310

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