# K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
- Decided: Feb 25, 2025 after 438 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162580: Guardian Angel GA1000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2017) Summary page 5.
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2022) Summary page 5.

## Indications for use
The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

Source page: https://510kreport.com/device/K233963
Methodology: https://510kreport.com/methodology