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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 / November 2025 / K250392

510(k) cleared

ZAP-X Radiosurgery System (ZAP-X)

Zap Surgical Systems, Inc. · Nov 3, 2025 · K250392

FDA cleared the ZAP-X Radiosurgery System (ZAP-X) from Zap Surgical Systems, Inc. on Nov 3, 2025 under K250392, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 12, 2025. The decision came 264 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 Zap Surgical Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250392?

K250392 is the FDA 510(k) for ZAP-X Radiosurgery System (ZAP-X), submitted by Zap Surgical Systems, Inc.. FDA's decision date was Nov 3, 2025, under product code IYE (Accelerator, Linear, Medical).

Who makes the ZAP-X Radiosurgery System (ZAP-X)?

Zap Surgical Systems, Inc., based in San Carlos, CA, is the applicant of record for K250392.

How long did the K250392 review take?

FDA received the submission on Feb 12, 2025 and issued its decision on Nov 3, 2025, 264 days later.

← All decisions in November 2025