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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 / January 2026 / K252886

510(k) cleared

Pen Needle

Hh Global Technology, Inc. · Jan 6, 2026 · K252886

FDA cleared the Pen Needle from Hh Global Technology, Inc. on Jan 6, 2026 under K252886, a traditional 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 10, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hh Global Technology, Inc. has 2 other decisions in the tracker over the last 12 months: K262427 (Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)), K254239 (CyClean Cord).

Questions & Answers

What did FDA clear under K252886?

K252886 is the FDA 510(k) for Pen Needle, submitted by Hh Global Technology, Inc.. FDA's decision date was Jan 6, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Pen Needle?

Hh Global Technology, Inc., based in Buford, GA, is the applicant of record for K252886.

How long did the K252886 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Jan 6, 2026, 118 days later.

← All decisions in January 2026