# K011592: Oxygen Treatment Hood

- Pathway: 510(k) (Traditional)
- Applicant: Amron International Diving Supply, Inc.
- Decided: Jun 19, 2002 after 391 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 K010659 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010659: Sea-Long Medical Treatment Hood, Sea-Long Medical Systems, Inc. (2001) Summary page 2.

## Indications for use
The Amron International Treatment Hood is intended to provide a means to administer gas/oxygedair to a patient by a clinician in clinical multiplace or monoplace chamber systems.

Source page: https://510kreport.com/device/K011592
Methodology: https://510kreport.com/methodology