510(k) Report

FDA applicant

Sensor Medical Technology, LLC

Maple Valley, WA3 decisions2014–20150 recalls

FDA records 3 decisions for Sensor Medical Technology, LLC (Maple Valley, WA) from 2014 to 2015: 3 510(k) clearances. Most are in product codes HKS (Prism, Gonioscopic) and HKY (Tonometer, Manual). Its devices cite 2 predicates, 0 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, ophthalmic panel, where it files most

How often FDA has decided Sensor Medical Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 22015: 1
2014high 2 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Sensor Medical Technology, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HKSPrism, Gonioscopic1decision
  • HKYTonometer, Manual1decision
  • HJKLens, Contact, Polymethylmethacrylate, Diagnostic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K140368Family of Disposable LensesSensor Medical Technology, LLC · 20141cites it
  • K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 20141cites it

What has FDA decided for it lately?

  • K152308Sensor Medical Single Use Tonometer PrismSensor Medical Technology, LLC · 2015
  • K142715Sensor Medical Family of Vitrectomy Lenses and ProductsSensor Medical Technology, LLC · 2014
  • K140368Family of Disposable LensesSensor Medical Technology, LLC · 2014

All 3 as Sensor Medical Technology, LLC →

Other applicant names beginning “Sensor”

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

Sensor Medics Corp. 26Sensor Dynamics, Inc. 2