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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 / K252160

510(k) cleared

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Persyst Development, LLC · Oct 31, 2025 · K252160

FDA cleared the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) from Persyst Development, LLC on Oct 31, 2025 under K252160, a traditional 510(k). The device falls under product code OMB, Automatic Event Detection Software For Full-Montage Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 10, 2025. The decision came 113 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 Persyst Development, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252160?

K252160 is the FDA 510(k) for Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)), submitted by Persyst Development, LLC. FDA's decision date was Oct 31, 2025, under product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph).

Who makes the Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))?

Persyst Development, LLC, based in Solana Beach, CA, is the applicant of record for K252160.

How long did the K252160 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Oct 31, 2025, 113 days later.

← All decisions in October 2025