Atlas FDA

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

Arkray Factory, Inc. · Predicate Candidate Screening

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

219 daysmedian FDA review time
550 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K183306GLUCOCARD® W onyx Blood Glucose Monitoring SystemArkray Factory, Inc.2019-04-101330
K170064GLUCOCARD W Blood Glucose Monitoring SystemArkray Factory, Inc.2017-08-162190
K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc.2017-06-292650
K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Arkray Factory, Inc.2014-09-17270
K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MIArkray Factory, Inc.2014-09-05390
K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELIArkray Factory, Inc.2014-06-305500

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