# K222794: FlowStar Touch Digital Mixer Flowmeter

- Pathway: 510(k) (Traditional)
- Applicant: Baldus Sedation GmbH & Co. KG
- Decided: Jul 28, 2023 after 315 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 K945722 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052335: Analgesia Gas Machine, Model Digital Ultra, Accutron, Inc. (2005) Summary page 4.

## Most influential descendants
- K241465: Midas Flowmeter; eAVS (2024), 0 descendants of its own

## Indications for use
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.

Source page: https://510kreport.com/device/K222794
Methodology: https://510kreport.com/methodology