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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Home Uterine Activity Monitor
510(k) Number K253673
Device Name M•care System (MW-20)
Applicant
Marani Health, Inc.
3510 Hopkins Pl. N.
Oakdale,  MN  55128
Applicant Contact Mindy A. Ditch
Correspondent
Marani Health, Inc.
3510 Hopkins Pl. N.
Oakdale,  MN  55128
Correspondent Contact Mindy A. Ditch
Regulation Number884.2730
Classification Product Code
LQK  
Date Received11/21/2025
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Clinical Trials NCT05294211
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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