# K970163: Alpha MX (20)/Ultra PC (30)

- Pathway: 510(k) (Traditional)
- Applicant: Technical Medical Products, Inc.
- Decided: Dec 10, 1997 after 328 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052335: Analgesia Gas Machine, Model Digital Ultra (2005), 3 descendants of its own
- K222794: FlowStar Touch Digital Mixer Flowmeter (2023), 1 descendant of its own
- K241465: Midas Flowmeter; eAVS (2024), 0 descendants of its own
- K062155: Digital MXR-D Flowmeter (2006), 0 descendants of its own

## Indications for use
This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

Source page: https://510kreport.com/device/K970163
Methodology: https://510kreport.com/methodology