# K062300: OX-Sox, Model C, D, E,

- Pathway: 510(k) (Traditional)
- Applicant: Pattient Safety Innovations, Llp
- Decided: Nov 27, 2006 after 111 days
- Product code: ECX (Cylinder, Compressed Gas, And Valve)
- Device class: 1
- Regulation: 21 CFR 868.2700
- 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 Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders, both in healthcare facilities and for home use. The device is for use with gas cylinders containing oxygen.

Source page: https://510kreport.com/device/K062300
Methodology: https://510kreport.com/methodology