# K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Bird Products Corp.
- Decided: May 7, 1998 after 225 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: 1 generation back to K883038 (1988). 3 ancestors in all.
125 later devices descend from it; 3 cite it directly.
38 of 129 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 2.
- K911344: Cerion Hand Held Oxygen Analyzer, Ceramatec, Inc. (1991) Summary page 2.
- K883038: P/N 9320 Low Flow Air/Oxygen Microblender, Bird Products Corp. (1988) Summary page 2.

## Most influential descendants
- K020746: Bird Tbird Vela Ventilator (2002), 120 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own

## Indications for use
The modified Bird Sentry™ Blender is designed to provide a continuous air/oxygen gas mixture to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.

Source page: https://510kreport.com/device/K973646
Methodology: https://510kreport.com/methodology