Cleared Traditional

K243729 - Prismira (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243729 · Lumos Labs, Inc. · Neurology device
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Jun 2025
Decision
192d
Days
Class 2
Risk

K243729 is an FDA 510(k) clearance for the Prismira. Classified as Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder (product code QFT), Class II - Special Controls.

Submitted by Lumos Labs, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 13, 2025 after a review of 192 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5803 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lumos Labs, Inc. devices

Submission Details

510(k) Number K243729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2024
Decision Date June 13, 2025
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 148d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFT Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5803
Definition A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Aepis Medical
Adam Savakus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.