# DEN250046: Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)

- Pathway: De Novo (Direct)
- Applicant: Vitestro
- Decided: Aug 19, 2026 after 327 days
- Product code: SIW (Robotic Peripheral Venous Blood Collection System)
- Device class: 2
- Regulation: 21 CFR 880.6975
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Aletta® ARPD™ is intended to perform autonomous, ultrasound-guided, venipuncture and collection of blood for diagnostic purposes in adult outpatients, monitored by a trained phlebotomist. One phlebotomist may supervise up to three Aletta® ARPD™ devices simultaneously.

Source page: https://510kreport.com/device/DEN250046
Methodology: https://510kreport.com/methodology