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

DEN250046 Class II Direct
Decision Date
2026-08-19
Sponsor / Applicant
Vitestro

Technical Specification

510(k) Submission ID DEN250046
Product Code SIW
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6975
Decision Date 2026-08-19
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) received FDA 510(k) clearance under submission number DEN250046, sponsored by Vitestro. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-08-19.

Classification & Regulation

This clearance is catalogued under FDA product code SIW and 21 CFR 880.6975, within the General Hospital review panel as a Class II device.