# K212300: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mericonn Technology Co., Ltd.
- Decided: Feb 25, 2022 after 218 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: 14 generations back to K941811 (1994). 122 ancestors in all.
No later device cites it as a predicate yet.
1 of 123 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201468: Pulse Oximeter, Shenzhen Creative Industry Co., Ltd. (2021) Summary page 5.

## Indications for use
This Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in hospitals, clinics, or home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.

Source page: https://510kreport.com/device/K212300
Methodology: https://510kreport.com/methodology