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 / December 2025 / K251989

510(k) cleared

VizMark Preloaded Tissue Marker Device (VM-0001)

Breast-Med, Inc. · Dec 12, 2025 · K251989

FDA cleared the VizMark Preloaded Tissue Marker Device (VM-0001) from Breast-Med, Inc. on Dec 12, 2025 under K251989, a traditional 510(k). The device falls under product code NEU, Marker, Radiographic, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 27, 2025. The decision came 168 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 Breast-Med, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251989?

K251989 is the FDA 510(k) for VizMark Preloaded Tissue Marker Device (VM-0001), submitted by Breast-Med, Inc.. FDA's decision date was Dec 12, 2025, under product code NEU (Marker, Radiographic, Implantable).

Who makes the VizMark Preloaded Tissue Marker Device (VM-0001)?

Breast-Med, Inc., based in Hopkins, MN, is the applicant of record for K251989.

How long did the K251989 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Dec 12, 2025, 168 days later.

← All decisions in December 2025