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
K022214Substantially Equivalent

Msi I2010 Dual Place Hyperbaric Chamber

Mechidyne Systems, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022214 is the FDA 510(k) clearance record for MSI I2010 DUAL PLACE HYPERBARIC CHAMBER, a class II device, cleared for Mechidyne Systems, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Mechidyne Systems, Inc. As of , FDA records show no recalls naming K022214.

Clearance record

Decision date
Received
(233 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Mechidyne Systems, Inc. P.O. Box 840661, Houston TX
510(k) summary
Statement
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