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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K254058
Device Name DistaSense(TM) (v1)
Applicant
Life Detection Technologies
440 N Wolfe Rd.
Suite Wl 265
Sunnyvale,  CA  94085
Applicant Contact Peter Rule
Correspondent
Nilo Medical Consulting Group
3706 Butler St.
Suite #313
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
BZQ  
Date Received12/17/2025
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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