510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K193460Substantially Equivalent

The iNAP One Sleep Therapy System

Somnice, Inc., Hsinchu County, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193460 is the FDA 510(k) clearance record for The iNAP One Sleep Therapy System, a class II device, cleared for Somnice, Inc. on under FDA product code OZR (Intraoral Pressure Gradient Device). FDA's definition for product code OZR reads: "This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity...". FDA records list one 510(k) clearance for Somnice, Inc. As of , FDA records show no recalls naming K193460.

Clearance record

Decision date
Received
(162 days to decision)
Product code
OZR Intraoral Pressure Gradient Device
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Somnice, Inc. 5f, # 22, Sec. 2, Shengyi Rd., Hsinchu Science Park,, Hsinchu County, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZR

Trailing 12 months

FDA records hold no clearances under product code OZR in the trailing twelve months.

FDA records show no clearances under product code OZR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260