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FDA 510(k)

NEXT-Cue

K-Number: K261805 · 2026-10-08

ApplicantNeuroxt, Inc.
Decision Date2026-10-08
Product CodeQWT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEXT-Cue is the device name listed in this FDA 510(k) record. The listed applicant is Neuroxt, Inc.. It received FDA 510(k) clearance on 2026-10-08 under 510(k) number K261805. The device is classified under product code QWT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXT-Cue?

NEXT-Cue is a medical device that received FDA 510(k) clearance on 2026-10-08. The listed applicant is Neuroxt, Inc.. The 510(k) number is K261805.

When did NEXT-Cue receive FDA 510(k) clearance?

NEXT-Cue received FDA 510(k) clearance on 2026-10-08, under 510(k) number K261805.

Who is the listed applicant for NEXT-Cue?

The FDA 510(k) record lists Neuroxt, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXT-Cue?

The FDA product code for NEXT-Cue is QWT.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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