# K161179: Intelli-Ox

- Pathway: 510(k) (Traditional)
- Applicant: Air Liquide Healthcare America Corporation
- Decided: Apr 13, 2017 after 352 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
Longest line of descent: 3 generations back to K033897 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143060: Intelli-Ox, Air Liquide Healthcare (2015) Summary page 5.

## Indications for use
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.

Source page: https://510kreport.com/device/K161179
Methodology: https://510kreport.com/methodology