WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K252294

510(k) cleared

Fetal EchoScan (v1.2)

Brightheart · Dec 8, 2025 · K252294

FDA cleared the Fetal EchoScan (v1.2) from Brightheart on Dec 8, 2025 under K252294, a traditional 510(k). The device falls under product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2060 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 23, 2025. The decision came 138 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 Brightheart in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252294?

K252294 is the FDA 510(k) for Fetal EchoScan (v1.2), submitted by Brightheart. FDA's decision date was Dec 8, 2025, under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Who makes the Fetal EchoScan (v1.2)?

Brightheart, based in Paris, is the applicant of record for K252294.

How long did the K252294 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Dec 8, 2025, 138 days later.

← All decisions in December 2025