# K241086: Avidhrt Sense SpO2

- Pathway: 510(k) (Traditional)
- Applicant: Avidhrt, Inc.
- Decided: May 9, 2025 after 385 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: 20 generations back to K962603 (1997). 111 ancestors in all.
No later device cites it as a predicate yet.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2019) Summary page 5.

## Indications for use
Avidhrt Sense is a handheld spot-checking measurement device, indicated to do the following: • Non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is intended for use in adult patients in the home environment. The Avidhrt Sense SpO2 is not for continuous monitoring, use during motion or for patients with low perfusion. The Avidhrt Sense SpO2 is not intended for pediatric use.

Source page: https://510kreport.com/device/K241086
Methodology: https://510kreport.com/methodology