510(k) Report

FDA applicant

Oniris

Rueil Malmaison, FR2 decisions2016–20250 recalls

FDA records 2 decisions for Oniris (Rueil Malmaison, FR) from 2016 to 2025: 2 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sas Oniris”.

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

FDA decisions per year

1in 2025

2016: 12025: 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 — Oniris by year, 2016–2026Sources: 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; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K250353Oniris; Oniris PlusOniris · 2025
  • K150566OnirisSas Oniris · 2016

The one decision as Oniris →The one decision as Sas Oniris →