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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 / K253348

510(k) cleared

TargetCool-e

Recensmedical, Inc. · Oct 15, 2025 · K253348

FDA cleared the TargetCool-e from Recensmedical, Inc. on Oct 15, 2025 under K253348, a traditional 510(k). The device falls under product code GEH, Unit, Cryosurgical, Accessories, regulated at 21 CFR 878.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 30, 2025. The decision came 15 days later, inside the 90 FDA-day goal for a 510(k).

Recensmedical, Inc. has one other decision in the tracker over the last 12 months: K253114 (TargetCool (RM-DT02W)).

Questions & Answers

What did FDA clear under K253348?

K253348 is the FDA 510(k) for TargetCool-e, submitted by Recensmedical, Inc.. FDA's decision date was Oct 15, 2025, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the TargetCool-e?

Recensmedical, Inc., based in Hwaseong-Si, is the applicant of record for K253348.

How long did the K253348 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 15, 2025, 15 days later.

← All decisions in October 2025

Sources