Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6975](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6975) → SIW — Robotic Peripheral Venous Blood Collection System

# SIW · Robotic Peripheral Venous Blood Collection System

_General Hospital · 21 CFR 880.6975 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SIW

## Overview

- **Product Code:** SIW
- **Device Name:** Robotic Peripheral Venous Blood Collection System
- **Regulation:** [21 CFR 880.6975](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6975)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

The Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) is an electromechanical device intended to perform autonomous, ultrasound-guided, venipuncture and collection of blood for diagnostic purposes in adult outpatients, monitored by a trained phlebotomist. 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.

## Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250046](/device/DEN250046.md) | Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) | Vitestro | Aug 19, 2026 | DENG |

## Top Applicants

- Vitestro — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SIW](https://fda.innolitics.com/productcode/SIW)

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