510(k) Report

FDA applicant

Hmd Biomedical, Inc.

Xinpu Township, Hsinchu County, TW11 decisions2003–20220 recalls

FDA records 11 decisions for Hmd Biomedical, Inc. (Xinpu Township, Hsinchu County, TW) from 2003 to 2022: 11 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LFR (Glucose Dehydrogenase, Glucose). Its devices cite 13 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hmd Biomedical, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Hmd Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12012: 32013: 12014: 12015: 12019: 12022: 1
2007high 3 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hmd Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hmd Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter8decisions
  • LFRGlucose Dehydrogenase, Glucose3decisions

Whose devices does it build on?

Its devices cite 13 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 20085cite it
  • K032985Glucoleader Enhance Self-Monitoring of Blood Glucose SystemHmd Biomedical, Inc. · 20034cite it
  • K182428GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 20191cites it
  • K023279Glucoleader ValueHmd Biomedical, Inc. · 20031cites it
  • K113307GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 20121cites it
  • K120064Test, Blood Glucose SystemHmd Biomedical, Inc. · 20121cites it

What has FDA decided for it lately?

  • K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2022
  • K182428GlucoLeader Enhance Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2019
  • K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife…Hmd Biomedical, Inc. · 2015
  • K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014
  • K121433Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring…Hmd Biomedical, Inc. · 2013
  • K113314Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2012
  • K120064Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012
  • K113307GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 2012

All 10 as Hmd Biomedical, Inc. →The one decision as Hmd Biomedical, LLC →