Atlas FDA

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

Hmd Biomedical, Inc. — Predicate Candidate Screening

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

307 daysmedian FDA review time
511 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc.2022-08-294060
K182428GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc.2019-05-082440
K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife ACHmd Biomedical, Inc.2015-05-144770
K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.2014-09-185110
K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MHmd Biomedical, Inc.2013-02-142760
K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING Hmd Biomedical, Inc.2012-11-093660
K120064TEST, BLOOD GLUCOSE SYSTEMHmd Biomedical, Inc.2012-09-052400
K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.2012-07-272620
K032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEMHmd Biomedical, Inc.2003-10-21270
K023279GLUCOLEADER VALUEHmd Biomedical, Inc.2003-08-043070

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