DeviceClearance

Product code SIW— General Hospital

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

Classification name
Robotic Peripheral Venous Blood Collection System
Device class
Class 2
Regulation
21 CFR 880.6975
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SIW under 21 CFR 880.6975, via openFDA

Market context for product code SIW

FDA has cleared 1 device under product code SIW, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIW

Recent clearances under product code SIW

Data sourced from openFDA. This site is unofficial and independent of the FDA.