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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K251101
Device Name AIRO Suction Unit (AIRO-01)
Applicant
Cro, LLC
516 E Spruce St.
Missoula,  MT  59802
Applicant Contact Jeffrey Boardman
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/11/2025
Decision Date 04/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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