510(k) Report

FDA applicant

Ok Biotech Co., Ltd.

Hsinchu City, TW9 decisions2007–20220 recalls

FDA records 9 decisions for Ok Biotech Co., Ltd. (Hsinchu City, TW) from 2007 to 2022: 9 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 259 days from receipt to decision, against 239 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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 Ok Biotech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12010: 12014: 12015: 22016: 22017: 12022: 1
2007high 2 (2015) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ok Biotech Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ok Biotech Co., Ltd.’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 Counter9decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 259 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 239 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 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.

  • K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 20161cites it
  • K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 20151cites it
  • K090609Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 20101cites it

What has FDA decided for it lately?

  • K213061SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2022
  • K162430UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2017
  • K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016
  • K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2016
  • K142785PRODIGY iConnect Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2015
  • K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2015
  • K132633Okmeter Direct Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2014
  • K090609Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2010

All 9 as Ok Biotech Co., Ltd. →