# K240569: FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Fink Engineering Pty, Ltd.
- Decided: Nov 21, 2024 after 266 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 K930748 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031649: SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities, Fink Engineering Pty, Ltd. (2003) Summary page 5.

## Indications for use
The conditions listed as appropriate for the use of HBO recognized by the Undersea & Hyperbaric Medical Society's (UHMS) Hyperbaric Oxygen Therapy Committee Report, as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myonecrosis and myonecrosis 4. Crush injuries, compartment syndrome, and other acute traumatic ischemias 5. Decompression sickness 6. Enhancement of healing of selected problem wounds 7. Exceptional blood loss anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractory) 10. Delayed radiation injuries (soft tissue and bony necrosis) 11. Compromised grafts and flaps 12. Acute Thermal Burn Injury 13. Intracranial abscess

Source page: https://510kreport.com/device/K240569
Methodology: https://510kreport.com/methodology