# K252448: AViTA Pulse Oximeter (SP61)

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Feb 27, 2026 after 207 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 6.

## Indications for use
The AViTA Pulse Oximeter is intended for spot check monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults, adolescents and child in home and professional healthcare facility settings. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches ~0.9 inches) and intended for use during no-motion condition. The device is prescription only

Source page: https://510kreport.com/device/K252448
Methodology: https://510kreport.com/methodology