510(k) Report

FDA applicant

Zelegent, Inc.

Irvine, CA2 decisions2018–20220 recalls

FDA records 2 decisions for Zelegent, Inc. (Irvine, CA) from 2018 to 2022: 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.

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 Zelegent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12022: 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 — Zelegent, Inc. 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?

  • 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:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc. · 20181cites it

What has FDA decided for it lately?

  • K213475Elevo Snoring Intervention SetZelegent, Inc. · 2022
  • K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc. · 2018

All 2 as Zelegent, Inc. →