# K092484: Heliox Low Flow Sentry Blender

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health 207, Inc.
- Decided: Apr 2, 2010 after 232 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: 3 generations back to K925982 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911962: Bird Sentry Air/Oxygen Microblender, Bird Products Corp. (1991) Summary page 1.
- K883038: P/N 9320 Low Flow Air/Oxygen Microblender, Bird Products Corp. (1988) Summary page 1.
- K090781: HELIO2 Blender, Precision Medical, Inc. (2009) Summary page 1.

## Indications for use
The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen gas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21 % Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.

Source page: https://510kreport.com/device/K092484
Methodology: https://510kreport.com/methodology