# K053117: EZ-OX Plus

- Pathway: 510(k) (Traditional)
- Applicant: Air Liquide Healthcare America
- Decided: Apr 10, 2006 after 154 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: 1 generation back to K033897 (2004). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033897: Medicyl-E-Lite Portable Oxygen Delivery System, Aga-Linde Health Care (2004) Summary page 2.

## Most influential descendants
- K143060: Intelli-Ox (2015), 1 descendant of its own
- K131386: EZ-OX Plus Generation II (2014), 1 descendant of its own
- K161179: Intelli-Ox (2017), 0 descendants of its own
- K142149: Oxytote Infinity Series Vipr Systems (2015), 0 descendants of its own
- K080243: Portable Oxygen Unit SCA900 (2009), 0 descendants of its own

## Indications for use
The EZ-OX Plus is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and medical E-Oxygen cylinder with handle and shroud all integrated into a single, lightweight unit. Key specifications include hose barb connection, protective cap, carrying handle, easy to read content gauge, indexed flow meter, integrated regulator and usage chart label with safety instructions. Medical personnel can concentrate on providing patient care and treatment sooner without delays caused by the need to mount a regulator. With no assembly needed and the easy-to-use design, it is easy to operate. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

Source page: https://510kreport.com/device/K053117
Methodology: https://510kreport.com/methodology