# K182822: Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
- Decided: Mar 1, 2019 after 148 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). 21 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040589: Modification to Avant 9600 Pulse Oximeter, Nonin Medical, Inc. (2004) Summary page 5.

## Most influential descendants
- K191207: Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (2019), 4 descendants of its own
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (2022), 3 descendants of its own
- 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
The Guardian Angel Rx GA1001 Digital Vital Sign Monitoring System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of pediatrics and infants during non-motion and under well-perfused conditions. The intended environments of use are hospitals, medical facilities, home care, and subacute environments. This system is a reusable device.

Source page: https://510kreport.com/device/K182822
Methodology: https://510kreport.com/methodology