510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250353Substantially Equivalent

Oniris; Oniris Plus

Oniris, Rueil Malmaison, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250353 is the FDA 510(k) clearance record for Oniris; Oniris Plus, a class II device, cleared for Oniris on under FDA product code LRK (Device, Anti-Snoring). FDA records list one 510(k) clearance for Oniris. As of , FDA records show no recalls naming K250353.

Clearance record

Decision date
Received
(209 days to decision)
Product code
LRK Device, Anti-Snoring
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Oniris 147 Ave. Paul Doumer, Rueil Malmaison, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRK

Trailing 12 months
13 clearances under product code LRK in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LRK, trailing twelve months
MonthClearances
November 20253
December 20252
January 20260
February 20260
March 20262
April 20261
May 20261
June 20262
July 20261
August 20261
September 20260
October 20260