# K032516: HIOX80 Aerosol Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Mar 4, 2004 after 203 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 no predicate by number.

## Indications for use
The Hi-Ox 80 High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.

Source page: https://510kreport.com/device/K032516
Methodology: https://510kreport.com/methodology