WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / April 2026 / K260903

510(k) cleared

Hot Pink Pad Warming System

Xodus Medical, Inc. · Apr 16, 2026 · K260903

FDA cleared the Hot Pink Pad Warming System from Xodus Medical, Inc. on Apr 16, 2026 under K260903, a traditional 510(k) reviewed through the Third Party Review Program. 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 Mar 18, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xodus Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260903?

K260903 is the FDA 510(k) for Hot Pink Pad Warming System, submitted by Xodus Medical, Inc.. FDA's decision date was Apr 16, 2026, under product code DWJ (System, Thermal Regulating).

Who makes the Hot Pink Pad Warming System?

Xodus Medical, Inc., based in New Kensington, PA, is the applicant of record for K260903.

How long did the K260903 review take?

FDA received the submission on Mar 18, 2026 and issued its decision on Apr 16, 2026, 29 days later.

← All decisions in April 2026