# K172792: Handheld Pulse Oximeter, Model SP-20

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Nov 13, 2018 after 424 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: 12 generations back to K941811 (1994). 120 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K123711: Patient Monitor, Shenzhen Creative Industry Co., Ltd. (2013) Summary page 5.
- K052693: PM-50 Pulse Oximeter, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 5.

## Most influential descendants
- K201468: Pulse Oximeter (2021), 2 descendants of its own
- K213431: Handheld Pulse Oximeter (2023), 0 descendants of its own
- K212300: Pulse Oximeter (2022), 0 descendants of its own

## Indications for use
The Handheld Pulse Oximeter is intended for measuring and displaying the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.

Source page: https://510kreport.com/device/K172792
Methodology: https://510kreport.com/methodology