510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050153Substantially Equivalent

Spirit, Model Has

Caire, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050153 is the FDA 510(k) clearance record for SPIRIT, MODEL HAS, a class II device, cleared for Caire, Inc. on under FDA product code BYJ (Unit, Liquid-Oxygen, Portable). FDA records list 2 510(k) clearances for Caire, Inc., from to . As of , FDA records show one recall naming K050153.

Clearance record

Decision date
Received
(81 days to decision)
Product code
BYJ Unit, Liquid-Oxygen, Portable
Regulation
21 CFR 868.5655
Device class
Class II
Review panel
Anesthesiology
Applicant
Caire, Inc. 1800 Sandy Plains Industrial, Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BYJ

Trailing 12 months

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

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