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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K254114
Device Name Baylis Connector Cable
Applicant
Baylis Medical Technologies, Inc.
2645 Matheson Blvd. E, Mississauga, On L4w 5m2
Mississauga,  CA L4W 5S4
Applicant Contact Barb Boyce
Correspondent
Baylis Medical Technologies, Inc.
2645 Matheson Blvd. E, Mississauga, On L4w 5m2
Mississauga,  CA L4W 5S4
Correspondent Contact Barb Boyce
Regulation Number870.2900
Classification Product Code
DSA  
Date Received12/19/2025
Decision Date 01/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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