SGB · Class II · 21 CFR 882.1472

FDA Product Code SGB: Pain Assessment Software In Non-communicative Adults

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.

Leading manufacturers include Painchek Limited (Ltd.).

1
Total
0
Cleared
299d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Pain Assessment Software In Non-communicative Adults Devices (Product Code SGB)

1 devices
1–1 of 1
Not Cleared Oct 06, 2025
PainChek (PainChek Adult)
DEN240073
Painchek Limited (Ltd.)
Neurology · 299d

About Product Code SGB - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGB since 2025, with 0 receiving FDA clearance (average review time: 299 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGB devices are reviewed by the Neurology panel. Browse all Neurology devices →