De Novo grant
Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)
Vitestro · 19 Aug 2026 · DEN250046
- Decision
- Unknown
- Decision date
- 19 Aug 2026
- Application received
- 26 Sept 2025
- Company
- Vitestro
- Device type
- Product code (SIW)
What it means
A De Novo grant clears a new kind of low-to-moderate-risk device that has nothing similar already on the market. Later devices of the same kind can then be cleared by comparison with it. See De Novo, explained.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.