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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 / K253847

510(k) cleared

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

Merit Medical Ireland, Ltd. · Jan 31, 2026 · K253847

FDA cleared the Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) from Merit Medical Ireland, Ltd. on Jan 31, 2026 under K253847, a special 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 2, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Merit Medical Ireland, Ltd. has 3 other decisions in the tracker over the last 12 months: K261640 (Merit MAK Nitinol/Gold-Tungsten Guide Wire), K254137 (InQwire Amplatz Guide Wire), K251385 (InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)).

Questions & Answers

What did FDA clear under K253847?

K253847 is the FDA 510(k) for Splashwire Hydrophilic Guide Wire (MSWSTD35150J3), submitted by Merit Medical Ireland, Ltd.. FDA's decision date was Jan 31, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

Merit Medical Ireland, Ltd., based in Galway, is the applicant of record for K253847.

How long did the K253847 review take?

FDA received the submission on Dec 2, 2025 and issued its decision on Jan 31, 2026, 60 days later.

← All decisions in January 2026