# K050153: Spirit, Model Has

- Pathway: 510(k) (Traditional)
- Applicant: Caire, Inc.
- Decided: Apr 15, 2005 after 81 days
- Product code: BYJ (Unit, Liquid-Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5655
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933930 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013251: Spirit 300, Caire, Inc. (2001) Summary page 1.

## Most influential descendants
- K071461: Model 300D Home Oxygen Liquefier (2007), 0 descendants of its own

## Recalls of this device
- Oct 23, 2007 · Not classified · Z-1716-2008: Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.

## Indications for use
The Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life-sustaining nor life-supporting device.

Source page: https://510kreport.com/device/K050153
Methodology: https://510kreport.com/methodology