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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 / February 2026 / K252098

510(k) cleared

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

Methyl Co., Ltd. · Feb 18, 2026 · K252098

FDA cleared the PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) from Methyl Co., Ltd. on Feb 18, 2026 under K252098, a traditional 510(k). The device falls under product code MEG, Syringe, Antistick, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 3, 2025. The decision came 230 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 Methyl Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252098?

K252098 is the FDA 510(k) for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED), submitted by Methyl Co., Ltd.. FDA's decision date was Feb 18, 2026, under product code MEG (Syringe, Antistick).

Who makes the PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

Methyl Co., Ltd., based in Taipei, is the applicant of record for K252098.

How long did the K252098 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Feb 18, 2026, 230 days later.

← All decisions in February 2026