# K242876: Pulse Oximeter ( PO2, PO2A, PO2B)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Viatom Technology Co., Ltd.
- Decided: Feb 28, 2025 after 158 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: 18 generations back to K941811 (1994). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191088: Checkme O2 Pulse Oximeter, Shenzhen Viatom Technology Co., Ltd. (2019) Summary page 5.

## Indications for use
The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

Source page: https://510kreport.com/device/K242876
Methodology: https://510kreport.com/methodology