# K190869: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Aeon Technology Co., Ltd.
- Decided: Sep 13, 2019 after 163 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: 5 generations back to K001085 (2000). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153021: Fingertip Pulse Oximeter A310, Amemo, Inc. (2016) Summary page 4.

## Most influential descendants
- K200414: Pulse Oximeter (2020), 1 descendant of its own
- K203812: Oxyfit Pulse Oximeter (2022), 0 descendants of its own
- K210274: Fingertip Pulse Oximeter (2021), 0 descendants of its own
- K201294: Pulse Oximeter (2020), 0 descendants of its own

## Indications for use
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

Source page: https://510kreport.com/device/K190869
Methodology: https://510kreport.com/methodology