# K200537: Oxxiom

- Pathway: 510(k) (Traditional)
- Applicant: True Wearables, Inc.
- Decided: Jul 3, 2020 after 122 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: 8 generations back to K910772 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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 4.

## Indications for use
The Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It may be used for spot checking, intermittent monitoring, and/or data collection of patients 12 years and older in low acuity settings in facilities such as hospitals, clinics and doctor's offices. It can also be used in home healthcare settings under prescription use. It is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K200537
Methodology: https://510kreport.com/methodology