# K211400: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technology Co., Ltd.
- Decided: Feb 11, 2022 after 282 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: 20 generations back to K962603 (1997). 114 ancestors in all.
No later device cites it as a predicate yet.
1 of 115 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2019) Summary page 5.
- 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. Respiratory rate (RR) is intended for adults only. The Pulse Oximeter is intended for use in hospitals, hospital-type facilities and homecare environment. The Pulse Oximeter is not intended for patients with: - cardiopulmonary disease - cardiac dysrhythmias, unstable patients, or patients in the ICU - respiratory insufficiency or recovering from surgery or trauma - morbid obesity - severe arrhythmia The Pulse Oximeter is not intended for patients who are: - injured, disabled or physically deformed - pregnant or lactating - taking drugs that stain the blood. The Pulse Oximeter is not designed to detect apneas.

Source page: https://510kreport.com/device/K211400
Methodology: https://510kreport.com/methodology