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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 / K254278

510(k) cleared

Arterial Pressure Monitoring Set/Tray

Spectrum Vascular · Mar 25, 2026 · K254278

FDA cleared the Arterial Pressure Monitoring Set/Tray from Spectrum Vascular on Mar 25, 2026 under K254278, a special 510(k). The device falls under product code DQO, Catheter, Intravascular, Diagnostic, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 30, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Spectrum Vascular has 3 other decisions in the tracker over the last 12 months: K260165 (Unimpregnated Central Venous Catheter), K261455 (Arterial Pressure Monitoring Set/Tray), K252373 (BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology).

Questions & Answers

What did FDA clear under K254278?

K254278 is the FDA 510(k) for Arterial Pressure Monitoring Set/Tray, submitted by Spectrum Vascular. FDA's decision date was Mar 25, 2026, under product code DQO (Catheter, Intravascular, Diagnostic).

Who makes the Arterial Pressure Monitoring Set/Tray?

Spectrum Vascular, based in White Plains, NY, is the applicant of record for K254278.

How long did the K254278 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Mar 25, 2026, 85 days later.

← All decisions in March 2026