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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 / K252289

510(k) cleared

Eva Scalp Cooling System

Stemtech Medical Devices Private Limited · Nov 25, 2025 · K252289

FDA cleared the Eva Scalp Cooling System from Stemtech Medical Devices Private Limited on Nov 25, 2025 under K252289, a traditional 510(k). The device falls under product code PMC, Scalp Cooling System, regulated at 21 CFR 878.4360 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 23, 2025. The decision came 125 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 Stemtech Medical Devices Private Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252289?

K252289 is the FDA 510(k) for Eva Scalp Cooling System, submitted by Stemtech Medical Devices Private Limited. FDA's decision date was Nov 25, 2025, under product code PMC (Scalp Cooling System).

Who makes the Eva Scalp Cooling System?

Stemtech Medical Devices Private Limited, based in Navi Mumbai, is the applicant of record for K252289.

How long did the K252289 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Nov 25, 2025, 125 days later.

← All decisions in November 2025