510(k) Report

FDA applicant

I-Sens, Inc.

Seoul, KR28 decisions2008–20260 recalls

FDA records 28 decisions for I-Sens, Inc. (Seoul, KR) from 2008 to 2026: 28 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 17 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 I-Sens, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12009: 12010: 12011: 22012: 42013: 42015: 12016: 12017: 22018: 32019: 12020: 32021: 12022: 12023: 12026 (partial year): 1
2008high 4 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — I-Sens, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter22decisions
  • CGAGlucose Oxidase, Glucose3decisions
  • JINNitroprusside, Ketones (Urinary, Non-Quant.)2decisions
  • QRLMultiple Use Blood Lancet For Single Patient Use Only1decision

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 171 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 190 days; 8 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 22 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 17 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.

  • K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color)I-Sens, Inc. · 200912cite it
  • K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemI-Sens, Inc. · 20173cite it
  • K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 20162cite it
  • K080923Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA…I-Sens, Inc. · 20082cite it
  • K103396Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control SolutionI-Sens, Inc. · 20111cites it
  • K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. · 20181cites it

What has FDA decided for it lately?

  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc. · 2023
  • K222656LDE4 Lancing DeviceI-Sens, Inc. · 2022
  • K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemI-Sens, Inc. · 2021
  • K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc. · 2020
  • K192859CareSens S Clear BT Blood Glucose Monitoring SystemI-Sens, Inc. · 2020
  • K193590CareSens S Fit BT Blood Glucose Monitoring SystemI-Sens, Inc. · 2020
  • K192220ReliOn Premier Classic Blood Glucose Monitoring SystemI-Sens, Inc. · 2019

All 28 as I-Sens, Inc. →