SIW — Robotic Peripheral Venous Blood Collection System Class II
FDA product code SIW covers "Robotic Peripheral Venous Blood Collection System", a Class II medical device regulated under 21 CFR 880.6975. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIW
- Device Class
- Class II
- Regulation Number
- 880.6975
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250046 | Vitestro | Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) | Aug 19, 2026 |