# K030418: Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System

- Pathway: 510(k) (Traditional)
- Applicant: Makai Marine Industries, Inc.
- Decided: Jan 29, 2004 after 353 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
Longest line of descent: 2 generations back to K862198 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930748: Sigma MP Multiplace Hyperbaric Chamber, Perry Baromedical Services (1993) Summary page 1.
- K950957: Multiplace Hyperbaric Treatment Chamber System, Gulf Coast Hyperbarics, Inc. (1995) Summary page 1.
- K954387: T Class Hyperbaric Facilities, Reimers Systems, Inc. (1995) Summary page 3.
- K960389: Hyperbaric Chamber, Tampa Hyperbaric Ent. (1996) Summary page 1.

## Indications for use
The conditions listed as appropriate for the use of (HBO) in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myositis and Myonecrosis (Gas Gangrene) 4. Crush injury, compartment syndrome, and other acute traumatic lschemias 5. Decompression sickness 6. Enhanced healing of selected problem wounds 7. Exceptional blood loss anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractory) i0. Delayed radiation injury (soft tissue and bony necrosis) i 1. Skin grafts and flaps (compromised) 12. Thermal burns 13. Intracranial abscess

Source page: https://510kreport.com/device/K030418
Methodology: https://510kreport.com/methodology