Atlas FDA

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

All Medicus Co., Ltd. — Predicate Candidate Screening

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

171 daysmedian FDA review time
260 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170241GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE BloAll Medicus Co., Ltd.2017-10-132600
K130657LINKDR 2.0 DIABETES MANAGEMENT SOFTWAREAll Medicus Co., Ltd.2013-07-151250
K083628GLUCODR AUTO SYSTEMAll Medicus Co., Ltd.2009-05-011440
K082328GLUCODR PLUS SYSTEM, MODEL AGM-3000All Medicus Co., Ltd.2009-02-271970
K050985GLUCODR SUPERSENSOR SYSTEMAll Medicus Co., Ltd.2005-10-071710

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