# K041007: Millenium, Models 2000, 2001 and 2002

- Pathway: 510(k) (Traditional)
- Applicant: Hyperbaric For Life, LLC
- Decided: Nov 15, 2004 after 210 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K102831: RSI 4200 (2011), 0 descendants of its own

## Indications for use
The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current edition of the Undersea and Hyperbaric and Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1998) are as follows Air or gas embolism Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning Clostridial myositis and myonecrosis Crush injury, compartment syndrome, and other acute traumatic ischemias Decompression sickness Enhanced healing of selected problem wounds Exceptional blood loss anemia Necrotizing soft tissue infections Osteomyelitis (refractory) Delayed radiation injury (soft tissue and bone necrosis) Skin grafts and flaps (compromised) Thermal burns Intracranial abscess

Source page: https://510kreport.com/device/K041007
Methodology: https://510kreport.com/methodology