# K011565: Infant Oxygen Treatment Hood

- Pathway: 510(k) (Traditional)
- Applicant: Gulf Coast Hyperbarics, Inc.
- Decided: Aug 16, 2001 after 87 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
“The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.

Source page: https://510kreport.com/device/K011565
Methodology: https://510kreport.com/methodology