510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250046Unknown

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

Vitestro, Utrecht, NL / Direct, Unknown
FDA source (opens on fda.gov)

DEN250046 is the FDA 510(k) clearance record for Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US), cleared for Vitestro on under FDA product code SIW. As of , FDA records show no recalls naming DEN250046.

Clearance record

Decision date
Received
(327 days to decision)
Product code
SIW Robotic Peripheral Venous Blood Collection System
Regulation
21 CFR 880.6975
Device class
Class II
Review panel
General Hospital
Applicant
Vitestro Europalaan Unit 1.N.2, Utrecht, NL
Third party review
No

Clearances, product code SIW

Trailing 12 months
1 clearance under product code SIW in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260