510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K030418Substantially Equivalent

Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System

Makai Marine Industries, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030418 is the FDA 510(k) clearance record for MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM, a class II device, cleared for Makai Marine Industries, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Makai Marine Industries, Inc. As of , FDA records show no recalls naming K030418.

Clearance record

Decision date
Received
(353 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Makai Marine Industries, Inc. P.O. Box 272039, Boca Raton FL
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