# K202776: Fingertip pulse oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
- Decided: Mar 1, 2021 after 161 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)
- K161560: Fingertip Pulse Oximeter MD300CN310, Beijing Choice Electronic Technology Co., Ltd. (2016) Summary page 4.

## Indications for use
The Fingertip pulse oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities, and homecare.

Source page: https://510kreport.com/device/K202776
Methodology: https://510kreport.com/methodology