# K191088: Checkme O2 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Viatom Technology Co., Ltd.
- Decided: Dec 2, 2019 after 222 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: 17 generations back to K941811 (1994). 113 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172366: Wrist Pulse Oximeter, Beijing Choice Electronic Technology Co., Ltd. (2018) Summary page 4.
- K150869: Checkme Pro Health Monitor, Viatom Technology Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K242876: Pulse Oximeter ( PO2, PO2A, PO2B) (2025), 0 descendants of its own
- K213515: WesperO2 (2022), 0 descendants of its own

## Indications for use
The Oxiband Pulse Oximeter is a wrist pulse oximeter 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/K191088
Methodology: https://510kreport.com/methodology