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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 / December 2025 / K252605

510(k) cleared

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)

Medspira, LLC · Dec 5, 2025 · K252605

FDA cleared the mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) from Medspira, LLC on Dec 5, 2025 under K252605, a traditional 510(k). The device falls under product code FFX, System, Gastrointestinal Motility (Electrical), regulated at 21 CFR 876.1725 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 18, 2025. The decision came 109 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 Medspira, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252605?

K252605 is the FDA 510(k) for mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001), submitted by Medspira, LLC. FDA's decision date was Dec 5, 2025, under product code FFX (System, Gastrointestinal Motility (Electrical)).

Who makes the mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)?

Medspira, LLC, based in Minneapolis, MN, is the applicant of record for K252605.

How long did the K252605 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Dec 5, 2025, 109 days later.

← All decisions in December 2025