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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 / K252059

510(k) cleared

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

Artivion, Inc. · Oct 2, 2025 · K252059

FDA cleared the CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) from Artivion, Inc. on Oct 2, 2025 under K252059, a special 510(k). The device falls under product code OHA, Heart Valve, More Than Minimally Manipulated Allograft as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jul 1, 2025. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Artivion, Inc. has one other decision in the tracker over the last 12 months: P250055 (AMDS Hybrid Prosthesis).

Questions & Answers

What did FDA clear under K252059?

K252059 is the FDA 510(k) for CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00), submitted by Artivion, Inc.. FDA's decision date was Oct 2, 2025, under product code OHA (Heart Valve, More Than Minimally Manipulated Allograft).

Who makes the CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)?

Artivion, Inc., based in Kennesaw, GA, is the applicant of record for K252059.

How long did the K252059 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Oct 2, 2025, 93 days later.

← All decisions in October 2025