# K031649: SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities

- Pathway: 510(k) (Abbreviated)
- Applicant: Fink Engineering Pty, Ltd.
- Decided: Dec 5, 2003 after 191 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 K930748 (1993). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 9 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 1.

## Most influential descendants
- K152223: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (2016), 1 descendant of its own
- K240569: FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (2024), 0 descendants of its own
- K163109: OxyHeal 4000 Multiplace Hyperbaric Chamber Family (2017), 0 descendants of its own
- K082455: Rectangular Multiplace Hyperbaric Chamber (2009), 0 descendants of its own
- K053498: Hyperox 101 (2006), 0 descendants of its own

## Indications for use
1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myositis and myonecrosis 4. Crush injury, compartment syndrome, and other acute traumatic ischemias 5. Decompression sickness 6. Enhanced healing of selected problem wounds 7. Exceptional anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractory) 10. Delayed radiation injury (soft tissue and bony necrosis) 11. Skin grafts and flaps (compromised) 12. Thermal burns 13. Intracranial abscess

Source page: https://510kreport.com/device/K031649
Methodology: https://510kreport.com/methodology