510(k) Report

FDA applicant

Eps Bio Technology Corp.

Hsinchu, TW25 decisions2005–20261 recall

FDA records 25 decisions for Eps Bio Technology Corp. (Hsinchu, TW) from 2005 to 2026: 25 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LFR (Glucose Dehydrogenase, Glucose). Since 2016 its 510(k)s took a median of 230 days from receipt to decision, against 179 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “EPS Bio Technology Corp.”.

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 Eps Bio Technology Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12008: 12009: 52010: 22011: 52012: 22014: 32018: 12019: 12021: 12026 (partial year): 1
2007high 5 (2009) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Eps Bio Technology Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter15decisions
  • LFRGlucose Dehydrogenase, Glucose6decisions
  • CGAGlucose Oxidase, Glucose4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 230 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 179 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K121207Easymax MU Self Monitoring Blood Glucose System, Easymax MU Pro Self Monitoring Blood Glucose SystemEps Bio Technology Corp. · 20122cite it
  • K043245Eps Easy Pain Supreme Self Monitoring Blood Glucose SystemEps Bio Technology Corp. · 20051cites it
  • K061992Easyplus Self Monitoring Glucose Test System, Model EPS04014Eps Bio Technology Corp. · 20061cites it
  • K133389EM40 Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 20141cites it

What has FDA decided for it lately?

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K201258EASYMAX Tag Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2021
  • K190189MDT2 BLE Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2019
  • K182057EasyMax BT Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2018
  • K133537EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
  • K133389EM40 Self-Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
  • K133647EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
  • K121207Easymax MU Self Monitoring Blood Glucose System, Easymax MU Pro Self Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2012

All 24 as Eps Bio Technology Corp. →The one decision as EPS Bio Technology Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083099EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits.…May 26, 2009