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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 / February 2026 / K252438

510(k) cleared

Explant Express

Applied Medical Technology, Inc. · Feb 3, 2026 · K252438

FDA cleared the Explant Express from Applied Medical Technology, Inc. on Feb 3, 2026 under K252438, a traditional 510(k). The device falls under product code QVS, Breast Implant Suction Retrieval Device, regulated at 21 CFR 878.4675 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 1, 2025. The decision came 186 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 Applied Medical Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252438?

K252438 is the FDA 510(k) for Explant Express, submitted by Applied Medical Technology, Inc.. FDA's decision date was Feb 3, 2026, under product code QVS (Breast Implant Suction Retrieval Device).

Who makes the Explant Express?

Applied Medical Technology, Inc., based in Brecksville, OH, is the applicant of record for K252438.

How long did the K252438 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Feb 3, 2026, 186 days later.

← All decisions in February 2026