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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 / K260278

510(k) cleared

ThermAffyx(TM) Patient Safety System

Stihler Electronic GmbH · Jul 8, 2026 · K260278

FDA cleared the ThermAffyx(TM) Patient Safety System from Stihler Electronic GmbH on Jul 8, 2026 under K260278, a traditional 510(k). The device falls under product code DWJ, System, Thermal Regulating, regulated at 21 CFR 870.5900 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 29, 2026. The decision came 160 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 Stihler Electronic GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260278?

K260278 is the FDA 510(k) for ThermAffyx(TM) Patient Safety System, submitted by Stihler Electronic GmbH. FDA's decision date was Jul 8, 2026, under product code DWJ (System, Thermal Regulating).

Who makes the ThermAffyx(TM) Patient Safety System?

Stihler Electronic GmbH, based in Leinfelden-Echterdingen, is the applicant of record for K260278.

How long did the K260278 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on Jul 8, 2026, 160 days later.

← All decisions in July 2026