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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K253404
Device Name CLEAR™ Aspiration System
Applicant
Insera Therapeutics, Inc.
5546 Serrano Ave.
Dallas,  TX  75248
Applicant Contact Vallabh Janardhan
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washingon,  DC  20004
Correspondent Contact Lina Kontos
Date Received09/30/2025
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
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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