510(k) Report

FDA applicant

Distar, Inc.

Winchester, VA2 decisions1997–20140 recalls

FDA records 2 decisions for Distar, Inc. (Winchester, VA) from 1997 to 2014: 2 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Distar, LLC”.

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

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

How often FDA has decided Distar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LRKDevice, Anti-Snoring2decisions

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.

  • K973038Adjustable TherasnoreDistar, Inc. · 19972cite it

What has FDA decided for it lately?

  • K140663TherasnoreDistar, LLC · 2014
  • K973038Adjustable TherasnoreDistar, Inc. · 1997

The one decision as Distar, Inc. →The one decision as Distar, LLC →