# K201468: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Jan 25, 2021 after 237 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: 13 generations back to K941811 (1994). 121 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 124 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172792: Handheld Pulse Oximeter, Model SP-20, Shenzhen Creative Industry Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K213431: Handheld Pulse Oximeter (2023), 0 descendants of its own
- K212300: Pulse Oximeter (2022), 0 descendants of its own

## 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 and continuous recording of SpO2, PR of adult or pediatric patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K201468
Methodology: https://510kreport.com/methodology