# K090781: HELIO2 Blender

- Pathway: 510(k) (Traditional)
- Applicant: Precision Medical, Inc.
- Decided: Aug 13, 2009 after 143 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- 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 K925982 (1993). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053232: Precision Blender, Precision Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K111640: Precision Flow (R) - Heliox (2011), 0 descendants of its own
- K092484: Heliox Low Flow Sentry Blender (2010), 0 descendants of its own

## Indications for use
The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium. The blender is not intended as a life supporting device.

Source page: https://510kreport.com/device/K090781
Methodology: https://510kreport.com/methodology