510(k) Report

FDA applicant

Labstyle Innovations, Ltd.

Charlott, NC2 decisions2015–20171 recall

FDA records 2 decisions for Labstyle Innovations, Ltd. (Charlott, NC) from 2015 to 2017: 2 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Labstyle Innovations, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 12017: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2015high 1 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Labstyle Innovations, Ltd. by year, 2015–2026Sources: 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 Counter2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 20152cite it

What has FDA decided for it lately?

  • K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2017
  • K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 20151 recall

All 2 as Labstyle Innovations, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150817Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software…Aug 29, 2019Class II

Other applicant names beginning “Labstyle”

FDA records each applicant name separately; these may or may not be the same firm.

Labstyle Innovation, Ltd. 1