# K020665: HI-OX

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Jul 30, 2002 after 151 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- 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-Ox8' High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

Source page: https://510kreport.com/device/K020665
Methodology: https://510kreport.com/methodology