# K253650: Anura Mobile Core SDK (M1)

- Pathway: 510(k) (Traditional)
- Applicant: Nuralogix Corporation
- Decided: Jun 11, 2026 after 203 days
- Product code: QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate)
- Device class: 2
- Regulation: 21 CFR 870.2785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913396 (1992). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK), Faceheart Corp. (2023) Summary page 5.
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR), Faceheart Corp. (2025) Summary page 5.

## Indications for use
Anura Mobile Core SDK (AMC-SDK) is designed to use Transdermal Optical Imaging (TOI) for non-invasive spot (discrete) measurement of pulse rate and breathing rate (chest wall movements) when the subject is relaxed, still, and seated upright. AMC-SDK can be used for general healthcare in adults 18 years of age or older, but is not designed to treat or diagnose patients. The measurement results should complement, but not replace, the user's professional medical care and/or medication. If abnormalities are detected during the measurement with the SDK, users are advised to consult a medical professional. AMC-SDK is not intended to be the sole method of checking the physical health of a subject. AMC-SDK is not desiqned to function as an apnea monitor or to detect cessation of breathinq_

Source page: https://510kreport.com/device/K253650
Methodology: https://510kreport.com/methodology