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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 / K250135

510(k) cleared

WAVE Clinical Platform (2.0.000)

Baxter Healthcare Corp/ Excel Medical · Jan 16, 2026 · K250135

FDA cleared the WAVE Clinical Platform (2.0.000) from Baxter Healthcare Corp/ Excel Medical on Jan 16, 2026 under K250135, a traditional 510(k). The device falls under product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 17, 2025. The decision came 364 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Baxter Healthcare Corp/ Excel Medical has one other decision in the tracker over the last 12 months: K251745 (Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)).

Questions & Answers

What did FDA clear under K250135?

K250135 is the FDA 510(k) for WAVE Clinical Platform (2.0.000), submitted by Baxter Healthcare Corp/ Excel Medical. FDA's decision date was Jan 16, 2026, under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Who makes the WAVE Clinical Platform (2.0.000)?

Baxter Healthcare Corp/ Excel Medical, based in Palm Beach Gardens, FL, is the applicant of record for K250135.

How long did the K250135 review take?

FDA received the submission on Jan 17, 2025 and issued its decision on Jan 16, 2026, 364 days later.

← All decisions in January 2026

Sources