510(k) clearance

Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)

FDA 510(k) source

510(k) number

DEN250046

Applicant

Vitestro

Decision date

Aug 19, 2026

Date received

Sep 26, 2025

Decision

Unknown

Clearance type

Direct

Product code

SIW

Device type

Robotic Peripheral Venous Blood Collection System

Device class

Class II

Regulation

21 CFR 880.6975

Advisory committee

General Hospital

Third party

N

Location

Utrecht, NL