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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 / April 2026 / K253048

510(k) cleared

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

Shenzhen Maiwei Biotech Co., Ltd. · Apr 16, 2026 · K253048

FDA cleared the High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube from Shenzhen Maiwei Biotech Co., Ltd. on Apr 16, 2026 under K253048, a traditional 510(k). The device falls under product code DXT, Injector And Syringe, Angiographic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 22, 2025. The decision came 206 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 Shenzhen Maiwei Biotech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253048?

K253048 is the FDA 510(k) for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube, submitted by Shenzhen Maiwei Biotech Co., Ltd.. FDA's decision date was Apr 16, 2026, under product code DXT (Injector And Syringe, Angiographic).

Who makes the High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

Shenzhen Maiwei Biotech Co., Ltd., based in Shenzhen, is the applicant of record for K253048.

How long did the K253048 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Apr 16, 2026, 206 days later.

← All decisions in April 2026