510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K033823Substantially Equivalent

Respironics Custom II Oral Appliance

Respironics, Inc., Murrysville PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033823 is the FDA 510(k) clearance record for RESPIRONICS CUSTOM II ORAL APPLIANCE, a class II device, cleared for Respironics, Inc. on under FDA product code LRK (Device, Anti-Snoring). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K033823.

Clearance record

Decision date
Received
(58 days to decision)
Product code
LRK Device, Anti-Snoring
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRK

Trailing 12 months
12 clearances under product code LRK in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LRK, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20262
April 20261
May 20261
June 20262
July 20261
August 20261
September 20260
October 20262
November 20260