# K082487: M-50 Series SPO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Mar 4, 2009 after 188 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: 4 generations back to K001085 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072825: Fingertip Pulse Oximeter, Model MD300I, Beijing Choice Electronic Technololgy Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K103685: Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI, RST063CA (2011), 0 descendants of its own

## Indications for use
The M-50 Series SpO2 Sensor is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment. The M-50A, M-50E and M-50G SpO2 Sensor is intended for adult patients in hospitals, hospital-type facilities, and home environments. The M-50B and M-50H SpO2 Sensor is intended for pediatric patients in hospitals, hospital-type facilities, and home environments. The M-50C SpO2 Sensor is intended for adult, pediatric, infant and neonatal patients in hospitals, hospital-type facilities, and home environments.

Source page: https://510kreport.com/device/K082487
Methodology: https://510kreport.com/methodology