# K060739: Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307

- Pathway: 510(k) (Special)
- Applicant: Khrunichev State Research & Production Space Centr
- Decided: Jul 21, 2006 after 123 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: 1 generation back to K011312 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011312: BLKS-303 MK Monoplace Hyperbaric System, Khrunichev State Research & Production Space Centr (2001) Summary page 2.

## Most influential descendants
- K072757: Dive and Shallow and Grand Dive (2008), 2 descendants of its own
- K171899: Revitalair 430F (2019), 1 descendant of its own
- K220290: Revitalair 430+ (2023), 0 descendants of its own

## Indications for use
The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) 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 bony necrosis) * Skin grafts and flaps (compromised) * Thermal burns * Intracranial abscess

Source page: https://510kreport.com/device/K060739
Methodology: https://510kreport.com/methodology