Cleared Special

Baylis Connector Cable

K254114 · Baylis Medical Technologies, Inc. · Cardiovascular
Jan 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K254114 is an FDA 510(k) clearance for the Baylis Connector Cable, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Baylis Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on January 18, 2026, 30 days after receiving the submission on December 19, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K254114 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2025
Decision Date January 18, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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