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
K852623Substantially Equivalent

Oxy-One

Ashai Co., Ltd., Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852623 is the FDA 510(k) clearance record for OXY-ONE, a class I device, cleared for Ashai Co. , Ltd. on under FDA product code BYG (Mask, Oxygen). FDA records list 12 510(k) clearances for Ashai Co. , Ltd., from to . As of , FDA records show no recalls naming K852623.

Clearance record

Decision date
Received
(90 days to decision)
Product code
BYG Mask, Oxygen
Regulation
21 CFR 868.5580
Device class
Class I
Review panel
Anesthesiology
Applicant
Ashai Co. , Ltd. 620 Harris St., Australia, AU
Third party review
No

Clearances, product code BYG

Trailing 12 months

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

FDA records show no clearances under product code BYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYG, 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