# K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
- Decided: Jun 12, 2022 after 590 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: 13 generations back to K962603 (1997). 80 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183067: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2019) Summary page 5.
- K191207: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2019) Summary page 6.
- K181013: Fever Scout, VivaLNK, Inc. (2018) Summary page 6.

## Most influential descendants
- K233963: Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (2025), 0 descendants of its own
- K233956: Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (2025), 0 descendants of its own
- K223721: Masimo Stork (2023), 0 descendants of its own

## Indications for use
GA2000 The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2000) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions. GA2001 The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2001) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions. GA2002 The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2002) is indicated for use in measuring, recording, and displaying body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants. GA2100 The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2100) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of adults and pediatrics during non-motion and under well-perfused conditions. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants. GA2101 The Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (Model GA2101) is indicated for use in measuring, recording, and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) and body temperature. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device. The Oximeter Module(s) is indicated for spot-checking and/or continuous monitoring of SpO2 and PR of pediatrics and infants during non-motion and under well-perfused conditions. The Thermometer Module is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants.

Source page: https://510kreport.com/device/K203208
Methodology: https://510kreport.com/methodology