Anura Mobile Core SDK (M1)— 510(k) K253650

Name: FDA 510(k) clearance K253650
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Substantially Equivalent

Nuralogix Corporation

FDA 510(k) clearance K253650 for Anura Mobile Core SDK (M1), Substantially Equivalent on 2026-06-11. Applicant: Nuralogix Corporation. Device class: 2.

Summary

Nuralogix's Anura Mobile Core SDK (M1) is filed under QME, software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. The record doesn't expand "SDK" or say which of those measurements this product makes.

Class II, 21 CFR 870.2785. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Nuralogix filed from Toronto, Canada. The decision came 203 calendar days after receipt (November 20, 2025 to June 11, 2026).

Clearance details

Applicant: Nuralogix Corporation
Product code: Product code QME
Device class: Class 2
Regulation: 21 CFR 870.2785
Advisory panel: Cardiovascular
Date received: 2025-11-20
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.