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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 / July 2026 / K260208

510(k) cleared

Ultra-Fine SAFETY Insulin Syringe

embecta Medical II, LLC · Jul 13, 2026 · K260208

FDA cleared the Ultra-Fine SAFETY Insulin Syringe from embecta Medical II, LLC on Jul 13, 2026 under K260208, a traditional 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 23, 2026. The decision came 171 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 embecta Medical II, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260208?

K260208 is the FDA 510(k) for Ultra-Fine SAFETY Insulin Syringe, submitted by embecta Medical II, LLC. FDA's decision date was Jul 13, 2026, under product code FMF (Syringe, Piston).

Who makes the Ultra-Fine SAFETY Insulin Syringe?

embecta Medical II, LLC, based in Parsippany, NJ, is the applicant of record for K260208.

How long did the K260208 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Jul 13, 2026, 171 days later.

← All decisions in July 2026