DEN240073 is an FDA 510(k) submission for the PainChek (PainChek Adult). This device is classified as a Pain Assessment Software In Non-communicative Adults (Class II - Special Controls, product code SGB).
Submitted by Painchek Limited (Ltd.) (Sydney, AU). The FDA issued a Not Cleared (DENG) decision on October 6, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1472. 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 Patients 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..
| 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 | - |
| Product Code | SGB - Pain Assessment Software In Non-communicative Adults |
| Device Class | Class II - 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 Patients 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. |