# K984313: HTU3

- Pathway: 510(k) (Traditional)
- Applicant: Hyox Systems, Ltd.
- Decided: Oct 22, 1999 after 324 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hyox Systems, Ltd.’s HTU2 Hyperbaric Chamber: named in the summary without a submission number
- (no number) Sechrist Industries’s Sechrist 2500E Hyperbaric Chamber: named in the summary without a submission number
- (no number) Sechrist Industries’s Sechrist 3200 Hyperbaric Chamber: named in the summary without a submission number

## Indications for use
To promote the movement of oxygen from the environment to a patient’s tissue by means of pressurization that is greater than atmospheric pressure, with non critical patients for the treatment of: 1. Air or Gas Embolism; 2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Poisoning Complicated by Cyanide Poisoning; 3. Clostridal Myonecrosis; 4. Crush Injury, Compartment Syndrome, Acute Traumatic Ischemias; 5. Decompression Sickness; 6. Enhancement of Healing in Selected Problem Wounds; 7. Exceptional Blood Loss; 8. Necrotizing Soft Tissue Infections; 9. Osteomyelitis (Refractory); 10. Radiation Tissue Damage; 11. Skin Grafts & Flaps (Compromised); 12. Thermal Burns; and 13. Adjunctive Hyperbaric Oxygen in Intracranial Abscess.

Source page: https://510kreport.com/device/K984313
Methodology: https://510kreport.com/methodology