# K210305: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Lingxin Technologies Co., Ltd.
- Decided: Dec 22, 2021 after 322 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082641: Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DL, Contec Medical System Co., Ltd. (2008) Summary page 5.

## Indications for use
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight > 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

Source page: https://510kreport.com/device/K210305
Methodology: https://510kreport.com/methodology