# K210032: Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)

- Pathway: 510(k) (Special)
- Applicant: Leadtek Research, Inc.
- Decided: Sep 1, 2021 after 239 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193350: Leadtek Fingertip Pulse Oximeter, Leadtek Research, Inc. (2020) Summary page 4.

## Indications for use
The Fingertip Pulse Oximeter (Wireless) are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition.

Source page: https://510kreport.com/device/K210032
Methodology: https://510kreport.com/methodology