# K030943: Modification to Hiox

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Apr 22, 2003 after 27 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.
8 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093261: MOVES (2010), 7 descendants of its own
- K141460: Finapres Nova Noninvasive Hemodynamic Monitor (2015), 4 descendants of its own
- K160967: Finapres Nova Noninvasive Hemodynamic Monitor (2017), 3 descendants of its own
- K173916: Finapres Nova Noninvasive Hemodynamic Monitor (2018), 2 descendants of its own
- K140049: Moves SLC (2014), 1 descendant of its own

## Indications for use
The Hi-OxEO High Fi02 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.

Source page: https://510kreport.com/device/K030943
Methodology: https://510kreport.com/methodology