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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 / June 2026 / K252933

510(k) cleared

DYNE PORT

Dyne Medical Group, Inc. · Jun 12, 2026 · K252933

FDA cleared the DYNE PORT from Dyne Medical Group, Inc. on Jun 12, 2026 under K252933, a traditional 510(k). The device falls under product code ODC, Endoscope Channel Accessory, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 15, 2025. The decision came 270 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 Dyne Medical Group, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252933?

K252933 is the FDA 510(k) for DYNE PORT, submitted by Dyne Medical Group, Inc.. FDA's decision date was Jun 12, 2026, under product code ODC (Endoscope Channel Accessory).

Who makes the DYNE PORT?

Dyne Medical Group, Inc., based in Gyeonggi-Do, is the applicant of record for K252933.

How long did the K252933 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Jun 12, 2026, 270 days later.

← All decisions in June 2026