# K992421: Guardian Low Pressure Alarm Accessory, Model 34076

- Pathway: 510(k) (Special)
- Applicant: Accutron, Inc.
- Decided: Oct 27, 1999 after 98 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Accessory device for use with nitrous oxide / oxygen sedation systems to monitor the medical gas system for a low oxygen pressure condition (less than 40 psi), and activate an audio alarm when this condition exists.

Source page: https://510kreport.com/device/K992421
Methodology: https://510kreport.com/methodology