# K071461: Model 300D Home Oxygen Liquefier

- Pathway: 510(k) (Traditional)
- Applicant: Copd Partners, Inc.
- Decided: Aug 21, 2007 after 88 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
Longest line of descent: 4 generations back to K933930 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042944: Home-Away System, Model 1041, In-X Corporation (2005) Summary page 1.
- K050153: Spirit, Model Has, Caire, Inc. (2005) Summary page 1.

## Indications for use
The Model 300D Home Oxygen Liquefier is intended for use in liquefying oxygen supplied by a concentrator equipped with an oxygen sensing device. The concentrator used with the home oxygen liquefier should generate >90% oxygen purity nominally, and alert the user if this purity drops to unacceptable levels. This liquid oxygen is intended for use with the liquid portable products rated for 93% oxygen such as the Caire Spirit 300 HAS product. This system and the associated portable are intended for use with 93% (+3%) oxygen.

Source page: https://510kreport.com/device/K071461
Methodology: https://510kreport.com/methodology