Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)— 510(k) DEN250046

Name: FDA 510(k) clearance DEN250046
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Unknown

Vitestro

FDA 510(k) clearance DEN250046 for Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US), Unknown on 2026-08-19. Applicant: Vitestro. Device class: 2.

Summary

Vitestro's Aletta Autonomous Robotic Phlebotomy Device (ARPD), listed as Gen1 US, is filed under product code SIW, robotic peripheral venous blood collection systems.

Class II, 21 CFR 880.6975. General Hospital is both the classification panel and the review panel. The record lists the submission type as Direct.

Vitestro filed from Utrecht, Netherlands. The decision date came 327 calendar days after the received date (September 26, 2025 to August 19, 2026).

Clearance details

Applicant: Vitestro
Product code: Product code SIW
Device class: Class 2
Regulation: 21 CFR 880.6975
Advisory panel: General Hospital
Date received: 2025-09-26
Decision date: 2026-08-19
Decision: Unknown
Clearance type: Direct
Location: Utrecht, NL

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