510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SIWClass II

Robotic Peripheral Venous Blood Collection System

21 CFR 880.6975 / General Hospital
FDA source (opens on fda.gov)

Classification record

Product code
SIW
Device name
Robotic Peripheral Venous Blood Collection System
FDA 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.
Regulation
21 CFR 880.6975
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SIW

By decision year
1 clearance under product code SIW with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SIW by decision year
YearClearances
20261

Applicants with the most clearances

Product code SIW
Applicants holding the most 510(k) clearances under product code SIW
ApplicantClearances
Vitestro1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SIW.