# K993220: Puritan-Bennett Helios Portable Liquid Oxygen System

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Oct 22, 1999 after 25 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: 1 generation back to K933930 (1994). 1 ancestor in all.
78 later devices descend from it; 4 cite it directly.
19 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933930: Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit, Puritan Bennett Corp. (1994) Summary page 1.

## Most influential descendants
- K041122: Precision Liquid Oxygen System (2004), 65 descendants of its own
- K062710: GE Datex-Ohmeda Engstrom Carestation (2006), 47 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own
- K093886: Engstrom Carestation, Engstrom Pro (2010), 21 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own

## Indications for use
The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient’s home. It is not intended as life sustaining or life supporting device. The device has no contraindications.

Source page: https://510kreport.com/device/K993220
Methodology: https://510kreport.com/methodology