510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN240073Unknown

PainChek (PainChek Adult)

PainChek Ltd., Sydney, AU / Direct, Unknown
FDA source (opens on fda.gov)

DEN240073 is the FDA 510(k) clearance record for PainChek (PainChek Adult), a class II device, cleared for Painchek Limited (Ltd.) on under FDA product code SGB (Pain Assessment Software In Non-Communicative Adults). FDA's definition for product code SGB reads: "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...". FDA records list one 510(k) clearance for Painchek Limited (Ltd.). As of , FDA records show no recalls naming DEN240073.

Clearance record

Decision date
Received
(299 days to decision)
Product code
SGB Pain Assessment Software In Non-Communicative Adults
Regulation
21 CFR 882.1472
Device class
Class II
Review panel
Neurology
Applicant
Painchek Limited (Ltd.) Suite 401, 35 Lime St., Sydney, AU
Third party review
No

Clearances, product code SGB

Trailing 12 months

FDA records hold no clearances under product code SGB in the trailing twelve months.

FDA records show no clearances under product code SGB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SGB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260