Not Cleared Direct

DEN240073 - PainChek (PainChek Adult) (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240073 · Painchek Limited (Ltd.) · Neurology device
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Oct 2025
Decision
299d
Days
Class 2
Risk

DEN240073 is an FDA 510(k) submission (not cleared) for the PainChek (PainChek Adult). Classified as Pain Assessment Software In Non-communicative Adults (product code SGB), Class II - Special Controls.

Submitted by Painchek Limited (Ltd.) (Sydney, AU). The FDA issued a Not Cleared (DENG) decision on October 6, 2025 after a review of 299 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1472 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 299 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Painchek Limited (Ltd.) devices

Submission Details

510(k) Number DEN240073 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 11, 2024
Decision Date October 06, 2025
Days to Decision 299 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 148d · This submission: 299d
Pathway characteristics

Device Classification

Product Code SGB Pain Assessment Software In Non-communicative Adults
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1472
Definition Pain Assessment Software In Non-communicative Adults Is A Prescription-only Device That Combines Information From Clinical Pain Domains To Produce An Output Indicative Of A Patient’s Current Level Of Pain In Conscious Adult Patients Who Are Unable To Communicate Their Current Pain Level. This Device Is Intended For Adjunctive Use And Not Intended As A Stand-alone Diagnostic Or Prognostic Tool.
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.