510(k) Report

FDA applicant

Blink Device Company

Seattle, WA2 decisions2018–20200 recalls

FDA records 2 decisions for Blink Device Company (Seattle, WA) from 2018 to 2020: 2 510(k) clearances. All are in product code KOI (Stimulator, Nerve, Peripheral, Electric). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Blink Device Corporation”.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Blink Device Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Blink Device Company by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KOIStimulator, Nerve, Peripheral, Electric2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K172843TwitchView SystemBlink Device Corporation · 20181cites it

What has FDA decided for it lately?

  • K192958TwitchView SystemBlink Device Company · 2020
  • K172843TwitchView SystemBlink Device Corporation · 2018

The one decision as Blink Device Company →The one decision as Blink Device Corporation →

Other applicant names beginning “Blink”

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

Blink Designs, Inc. 2