# K081206: Homelox

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 28, 2008 after 90 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- 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 HomeLox is intended to create and store liquid oxygen in a patient's home, so that a patient will be able to fill their liquid portable unit and ambulate. The device is intended only to be a LOX reservoir for filling a portable unit and will not provide the ability for the patient to breathe oxygen gas directly from the unit. The device is not intended to be life supporting nor life sustaining.

Source page: https://510kreport.com/device/K081206
Methodology: https://510kreport.com/methodology