# K253109: Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Best Electronics Co., Ltd.
- Decided: Jan 7, 2026 after 105 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). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153184: Caremed Reusable & Disposable SPO2 Sensors, Shenzhen Caremed Medical Technology Co., Ltd. (2017) Summary page 6.

## Indications for use
The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) patients.

Source page: https://510kreport.com/device/K253109
Methodology: https://510kreport.com/methodology