# K162580: Guardian Angel GA1000 Digital Vital Sign Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
- Decided: Mar 3, 2017 after 169 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: 7 generations back to K910772 (1991). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052669: Avant Digital Pulse Oximetry System, Model 4000, 4100, Nonin Medical, Inc. (2005) Summary page 4.

## Most influential descendants
- K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (2025), 0 descendants of its own
- K200537: Oxxiom (2020), 0 descendants of its own

## Indications for use
The Guardian Angel GA1000 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is indicated for spot-checking and / or continuous monitoring of patients during non-motion and under well-perfused conditions. The intended environment of use is hospital. This system is a reusable device.

Source page: https://510kreport.com/device/K162580
Methodology: https://510kreport.com/methodology