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
K152223Substantially Equivalent

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

Oxyheal Medical Systems, Inc., National City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152223 is the FDA 510(k) clearance record for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System, a class II device, cleared for Oxyheal Medical Systems, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list 2 510(k) clearances for Oxyheal Medical Systems, Inc., from to . As of , FDA records show no recalls naming K152223.

Clearance record

Decision date
Received
(266 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Oxyheal Medical Systems, Inc. 3224 Hoover Ave., National City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBF

Trailing 12 months

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

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