# K013251: Spirit 300

- Pathway: 510(k) (Traditional)
- Applicant: Caire, Inc.
- Decided: Dec 18, 2001 after 81 days
- Product code: BYJ (Unit, Liquid-Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5655
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933930 (1994). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800742: Liberator/Stroller II System, Cryogenic Assoc. (1980) Summary page 1.
- K993220: Puritan-Bennett Helios Portable Liquid Oxygen System, Puritan Bennett Corp. (1999) Summary page 1.
- K833994: Pulsair I & II, Cryo Corp. (1983) Summary page 1.

## Most influential descendants
- K072011: Copd Liquid Oxygen Portable, Model 300P (2007), 3 descendants of its own
- K090421: Model 350G Gas Conserver (2009), 2 descendants of its own
- K050153: Spirit, Model Has (2005), 1 descendant of its own
- K221014: Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile (2022), 0 descendants of its own
- K200401: Apogee (2020), 0 descendants of its own

## Indications for use
The CAIRE Spirit 300 will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 is neither a ||fe sustaining nor life supporting device.

Source page: https://510kreport.com/device/K013251
Methodology: https://510kreport.com/methodology