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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 / August 2026 / K261937

510(k) cleared

PacTemp Automix NE

The Belport Company Inc., DBA Gingi-Pak · Aug 7, 2026 · K261937

FDA cleared the PacTemp Automix NE from The Belport Company Inc., DBA Gingi-Pak on Aug 7, 2026 under K261937, a traditional 510(k). The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 10, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for The Belport Company Inc., DBA Gingi-Pak in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261937?

K261937 is the FDA 510(k) for PacTemp Automix NE, submitted by The Belport Company Inc., DBA Gingi-Pak. FDA's decision date was Aug 7, 2026, under product code EMA (Cement, Dental).

Who makes the PacTemp Automix NE?

The Belport Company Inc., DBA Gingi-Pak, based in Camarillo, CA, is the applicant of record for K261937.

How long did the K261937 review take?

FDA received the submission on Jun 10, 2026 and issued its decision on Aug 7, 2026, 58 days later.

← All decisions in August 2026