# K153518: Medipure Oxygen-LC System

- Pathway: 510(k) (Special)
- Applicant: Praxair Distribution, Incorporated.
- Decided: Jun 3, 2016 after 178 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: 4 generations back to K033897 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132778: Grab 'N GO Plus, Grab 'N GO Digital, Praxair Healthcare Services (2014) Summary page 5.

## Indications for use
The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.

Source page: https://510kreport.com/device/K153518
Methodology: https://510kreport.com/methodology