# K203812: Oxyfit Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Viatom Technology Co., Ltd.
- Decided: Nov 8, 2022 after 680 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 K001085 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200414: Pulse Oximeter, Shenzhen Aeon Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.

Source page: https://510kreport.com/device/K203812
Methodology: https://510kreport.com/methodology