510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852663Substantially Equivalent

Portable Gaseous Oxgyen Container

Cryogenic Assoc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852663 is the FDA 510(k) clearance record for PORTABLE GASEOUS OXGYEN CONTAINER, a class I device, cleared for Cryogenic Assoc. on under FDA product code CAN (Regulator, Pressure, Gas Cylinder). FDA records list 6 510(k) clearances for Cryogenic Assoc., from to . As of , FDA records show no recalls naming K852663.

Clearance record

Decision date
Received
(66 days to decision)
Product code
CAN Regulator, Pressure, Gas Cylinder
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
Cryogenic Assoc. 6565 Coffman Rd., Indianapolis IN
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