# K193350: Leadtek Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Leadtek Research, Inc.
- Decided: Apr 27, 2020 after 146 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: 4 generations back to K001085 (2000). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112843: Pulse Oximeter, Nonin Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K223399: AViTA Pulse Oximeter (2024), 1 descendant of its own
- K252448: AViTA Pulse Oximeter (SP61) (2026), 0 descendants of its own
- K242455: AViTA Pulse Oximeter (SP62B) (2025), 0 descendants of its own
- K210032: Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) (2021), 0 descendants of its own

## Indications for use
The Leadtek Fingertip Pulse Oximeter 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/K193350
Methodology: https://510kreport.com/methodology