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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 / December 2025 / K251745

510(k) cleared

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

Baxter Healthcare Corporation · Dec 16, 2025 · K251745

FDA cleared the Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) from Baxter Healthcare Corporation on Dec 16, 2025 under K251745, a traditional 510(k). The device falls under product code DXQ, Blood Pressure Cuff, regulated at 21 CFR 870.1120 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 6, 2025. The decision came 193 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Baxter Healthcare Corporation has one other decision in the tracker over the last 12 months: K250135 (WAVE Clinical Platform (2.0.000)).

Questions & Answers

What did FDA clear under K251745?

K251745 is the FDA 510(k) for Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs), submitted by Baxter Healthcare Corporation. FDA's decision date was Dec 16, 2025, under product code DXQ (Blood Pressure Cuff).

Who makes the Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

Baxter Healthcare Corporation, based in Deerfield Lake, IL, is the applicant of record for K251745.

How long did the K251745 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Dec 16, 2025, 193 days later.

← All decisions in December 2025

Sources