FDA 510(k) · Nuralogix
K253650: Anura Mobile Core SDK (M1) (Nuralogix Corporation)
Nuralogix Corporation received FDA 510(k) K253650 for Anura Mobile Core SDK (M1), with a decision date of Jun 11, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K253650 |
|---|---|
| Pathway | 510(k) |
| Applicant | Nuralogix Corporation |
| Device name | Anura Mobile Core SDK (M1) |
| Product code | QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| Regulation (21 CFR) | 870.2785 |
| Device class | Class 2 |
| Date received | Nov 20, 2025 |
| Decision date | Jun 11, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
? 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_
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QME is "Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate", class 2, 21 CFR 870.2785. FDA's definition: "The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy."
Our labels for filtering: claim Heart rate / pulse, sensor Camera (rPPG). These are heuristics, not FDA fields.