# K041122: Precision Liquid Oxygen System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Medical, Inc.
- Decided: Oct 4, 2004 after 158 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: 2 generations back to K933930 (1994). 2 ancestors in all.
65 later devices descend from it; 3 cite it directly.
19 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993220: Puritan-Bennett Helios Portable Liquid Oxygen System, Puritan Bennett Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own

## Recalls of this device
- Oct 4, 2006 · Not classified · Z-0153-2007: Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.

## Indications for use
The Precision Medical, Inc. Liquid Oxygen System is intended tQ provide supplemental oxygen to oxygen patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 4 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.

Source page: https://510kreport.com/device/K041122
Methodology: https://510kreport.com/methodology