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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 / K254114

510(k) cleared

Baylis Connector Cable

Baylis Medical Technologies, Inc. · Jan 18, 2026 · K254114

FDA cleared the Baylis Connector Cable from Baylis Medical Technologies, Inc. on Jan 18, 2026 under K254114, a special 510(k). The device falls under product code DSA, Cable, Transducer And Electrode, Patient, (Including Connector), regulated at 21 CFR 870.2900 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 19, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Baylis Medical Technologies, Inc. has 2 other decisions in the tracker over the last 12 months: K250275 (PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch), K251158 (PowerWire® 14 Radiofrequency Guidewire Kit).

Questions & Answers

What did FDA clear under K254114?

K254114 is the FDA 510(k) for Baylis Connector Cable, submitted by Baylis Medical Technologies, Inc.. FDA's decision date was Jan 18, 2026, under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)).

Who makes the Baylis Connector Cable?

Baylis Medical Technologies, Inc., based in Mississauga, is the applicant of record for K254114.

How long did the K254114 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Jan 18, 2026, 30 days later.

← All decisions in January 2026

Sources