510(k) Report

FDA applicant

Somnics, Inc.

Hsinchu County, TW2 decisions2016–20230 recalls

FDA records 2 decisions for Somnics, Inc. (Hsinchu County, TW) from 2016 to 2023: 2 510(k) clearances. Most are in product codes LRK (Device, Anti-Snoring) and OZR (Intraoral Pressure Gradient Device). 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, dental panel, where it files most

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

FDA decisions per year

1in 2023

2016: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Somnics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Somnics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LRKDevice, Anti-Snoring1decision
  • OZRIntraoral Pressure Gradient Device1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K220907The iNAP One Sleep Therapy SystemSomnics, Inc. · 2023
  • K152660HypnospadSomnics, Inc. · 2016

All 2 as Somnics, Inc. →