510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080243Substantially Equivalent

Portable Oxygen Unit Sca900

San Cheong Co., Ltd., Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080243 is the FDA 510(k) clearance record for PORTABLE OXYGEN UNIT SCA900, a class I device, cleared for San Cheong Co. , Ltd. on under FDA product code CAN (Regulator, Pressure, Gas Cylinder). FDA records list one 510(k) clearance for San Cheong Co. , Ltd. As of , FDA records show no recalls naming K080243.

Clearance record

Decision date
Received
(432 days to decision)
Product code
CAN Regulator, Pressure, Gas Cylinder
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
San Cheong Co. , Ltd. 13340 E Firestone Blvd., Santa Fe Springs CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAN

Trailing 12 months

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

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