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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 / July 2026 / K252978

510(k) cleared

ScioCardio ECG Analysis Platform

Synergen Technology Labs, LLC · Jul 9, 2026 · K252978

FDA cleared the ScioCardio ECG Analysis Platform from Synergen Technology Labs, LLC on Jul 9, 2026 under K252978, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 17, 2025. The decision came 295 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 Synergen Technology Labs, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252978?

K252978 is the FDA 510(k) for ScioCardio ECG Analysis Platform, submitted by Synergen Technology Labs, LLC. FDA's decision date was Jul 9, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the ScioCardio ECG Analysis Platform?

Synergen Technology Labs, LLC, based in Dallas, TX, is the applicant of record for K252978.

How long did the K252978 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Jul 9, 2026, 295 days later.

← All decisions in July 2026