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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name robotic peripheral venous blood collection system
De Novo Number DEN250046
Device Name Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
Requester
vitestro
europalaan unit 1.n.2
utrecht,  NL 3526 ks
Contact luuk giesen
Regulation Number880.6975
Classification Product Code
SIW  
Date Received09/26/2025
Decision Date 08/19/2026
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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