# K103685: Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI, RST063CA

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Rongrui-Century Scie. & Tech. Co., Ltd.
- Decided: Jul 15, 2011 after 210 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: 5 generations back to K001085 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082487: M-50 Series SPO2 Sensor, Beijing Choice Electronic Technololgy Co., Ltd. (2009) Summary page 2.
- K093853: Single-Patient Use Disposable Sensor Series, Nonin Medical, Inc. (2010) Summary page 2.

## Indications for use
The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the auto entlptet with oximeter equipment in hospitals, hospital-type facilities, and home care environments. The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or pediatric patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.

Source page: https://510kreport.com/device/K103685
Methodology: https://510kreport.com/methodology