# K022214: Msi I2010 Dual Place Hyperbaric Chamber - Pathway: 510(k) (Traditional) - Applicant: Mechidyne Systems, Inc. - Decided: Feb 26, 2003 after 233 days - Product code: CBF (Chamber, Hyperbaric) - Device class: 2 - Regulation: 21 CFR 868.5470 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. No later device cites it as a predicate yet. 0 of 1 device in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA’s file for it is a 510(k) statement, which names no predicate. ## Indications for use 1 Air or Gas Embolism 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3 Clostridal Myositis and Myonecrosis (Gas Gangrene) 4 Crush Iniury, Compartment Syndrome, and other Acute Traumatic lschemias 5 Decompression Sickness 6 Enhancement of Healing in Selected Problem Wounds 7 Exceptional Blood Loss