510(k) DEN250046
DEN250046 is an FDA 510(k) premarket notification submitted by Vitestro for the device "Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)". The FDA issued a decision of De Novo Granted on Aug 19, 2026. The device falls under product code SIW (Robotic Peripheral Venous Blood Collection System), a Class II device regulated under 21 CFR 880.6975.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Aug 19, 2026
- Date Received
- Sep 26, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Robotic Peripheral Venous Blood Collection System
- Device Class
- Class II
- Regulation Number
- 880.6975
- Review Panel
- HO
- Submission Type
A robotic peripheral venous blood collection system is an electromechanical device used to obtain blood samples from peripheral veins for diagnostic purposes. The device uses robotic systems to assist with the blood collection procedure, including vessel identification, targeting, and/or needle insertion, and may perform its functions in an automated or autonomous manner.