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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / DEN240073

510(k) cleared

PainChek (PainChek Adult)

Painchek Limited (Ltd.) · Oct 6, 2025 · DEN240073

FDA cleared the PainChek (PainChek Adult) from Painchek Limited (Ltd.) on Oct 6, 2025 under DEN240073, a direct 510(k). The device falls under product code SGB, Pain Assessment Software In Non-Communicative Adults, regulated at 21 CFR 882.1472 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 11, 2024. The decision came 299 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Painchek Limited (Ltd.) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN240073?

DEN240073 is the FDA 510(k) for PainChek (PainChek Adult), submitted by Painchek Limited (Ltd.). FDA's decision date was Oct 6, 2025, under product code SGB (Pain Assessment Software In Non-Communicative Adults).

Who makes the PainChek (PainChek Adult)?

Painchek Limited (Ltd.), based in Sydney, is the applicant of record for DEN240073.

How long did the DEN240073 review take?

FDA received the submission on Dec 11, 2024 and issued its decision on Oct 6, 2025, 299 days later.

← All decisions in October 2025