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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 / March 2026 / K252908

510(k) cleared

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

Sandstone Medical (Suzhou), Inc. · Mar 25, 2026 · K252908

FDA cleared the Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle from Sandstone Medical (Suzhou), Inc. on Mar 25, 2026 under K252908, a special 510(k). The device falls under product code FMI, Needle, Hypodermic, Single Lumen, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 12, 2025. The decision came 194 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 Sandstone Medical (Suzhou), Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252908?

K252908 is the FDA 510(k) for Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle, submitted by Sandstone Medical (Suzhou), Inc.. FDA's decision date was Mar 25, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle?

Sandstone Medical (Suzhou), Inc., based in Suzhou, is the applicant of record for K252908.

How long did the K252908 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Mar 25, 2026, 194 days later.

← All decisions in March 2026