# K033897: Medicyl-E-Lite Portable Oxygen Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Aga-Linde Health Care
- Decided: Jul 19, 2004 after 216 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MEDICYL-E-Lite Portable Oxygen System: named in the summary without a submission number
- (no number) Praxair Grab n' Go Portable Medical Oxygen System: named in the summary without a submission number

## Most influential descendants
- K063354: Linde Integrated Valve (Liv) (2007), 5 descendants of its own
- K053117: EZ-OX Plus (2006), 5 descendants of its own
- K101792: Liv Linde Intergrated Valve-Portable Oxygen System, Model M706 (2011), 3 descendants of its own
- K143060: Intelli-Ox (2015), 1 descendant of its own
- K132778: Grab 'N GO Plus, Grab 'N GO Digital (2014), 1 descendant of its own

## Indications for use
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.OT. 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/K033897
Methodology: https://510kreport.com/methodology