# K220101: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technology Co., Ltd.
- Decided: Mar 8, 2023 after 420 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: 11 generations back to K910772 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181503: Fingertip Pulse Oximeter, Beijing Choice Electronic Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
The 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, child and infant patients in hospitals, hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).

Source page: https://510kreport.com/device/K220101
Methodology: https://510kreport.com/methodology