# K223399: AViTA Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: May 20, 2024 after 558 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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 5.

## Most influential descendants
- K242455: AViTA Pulse Oximeter (SP62B) (2025), 0 descendants of its own

## Indications for use
The AViTA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.

Source page: https://510kreport.com/device/K223399
Methodology: https://510kreport.com/methodology