# K052335: Analgesia Gas Machine, Model Digital Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Accutron, Inc.
- Decided: Nov 23, 2005 after 89 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945722 (1994). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970163: Alpha MX (20)/Ultra PC (30), Technical Medical Products, Inc. (1997) Summary page 2.
- K945722: Matrx MDM, RA, Matrx Medical, Inc. (1994) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- Apr 29, 2012 · Class I · Z-0017-2013: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
- Apr 29, 2012 · Class I · Z-0020-2013: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
- Apr 29, 2012 · Class I · Z-0018-2013: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
- Apr 29, 2012 · Class I · Z-0019-2013: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.

## Indications for use
To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.

Source page: https://510kreport.com/device/K052335
Methodology: https://510kreport.com/methodology