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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 / K250979

510(k) cleared

Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)

Zoll Circulation, Inc. · Oct 15, 2025 · K250979

FDA cleared the Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) from Zoll Circulation, Inc. on Oct 15, 2025 under K250979, a traditional 510(k). The device falls under product code NZE, Hyperthermia Monitor, regulated at 21 CFR 870.5900 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 31, 2025. The decision came 198 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 Zoll Circulation, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250979?

K250979 is the FDA 510(k) for Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad), submitted by Zoll Circulation, Inc.. FDA's decision date was Oct 15, 2025, under product code NZE (Hyperthermia Monitor).

Who makes the Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)?

Zoll Circulation, Inc., based in San Jose, CA, is the applicant of record for K250979.

How long did the K250979 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Oct 15, 2025, 198 days later.

← All decisions in October 2025