# K972908: Sands Series Iii Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Sands Hyperbarics
- Decided: Jul 22, 1998 after 350 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 K840841 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840841: Reneau Unit, Reneau, Inc. (1984) Summary page 1.
- K950386: Model 3200P/3200PR Hyperbaric Chamber, Sechrist Industries, Inc. (1995) Summary page 1.

## Indications for use
APPROVED USES AND THRESHOLD LEVELS FOR THE NUMBER OF HYPERBARIC TREATMENTS (As published by the Undersea and Hyperbaric Medical Society's (UHMS) Oxygen Committee 1995) INDICATIONS Threshold Levels 1. Air or Gas Embolism 14 2. Carbon Monoxide Poisoning and Smoke Inhalation 10 3. Clostridial Myonecrosis (Gas Gangrene) 5* - 10 - 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic 3* - 12 Ischemias 5. Decompression Sickness Until improvement plateaus or 14 days 6. Enhanced Healing in Selected Problem Wounds 10* - 60 7. Exceptional Blood Loss (anemia) Until HCT 22.9% 8. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 5* - 30 9. Osteomyelitis (refractory) 20* - 60 10. Radiation Tissue Damage (Osteoradionecrosis) 10* - 60 11. Skin Grafts and Flaps (compromised) 6* - 40 12. Thermal Burns 5* - 45

Source page: https://510kreport.com/device/K972908
Methodology: https://510kreport.com/methodology