Not Cleared Direct

DEN250046 - Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)

DEN250046 · Vitestro · General Hospital
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Aug 2026
Decision
327d
Days
-
Risk

DEN250046 is an FDA 510(k) submission (not cleared) for the Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US).

Submitted by Vitestro (Utrecht, NL). The FDA issued a Not Cleared (DENG) decision on August 19, 2026 after a review of 327 days.

This device falls under the General Hospital FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 327 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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FDA 510(k) Submission Details - DEN250046

510(k) Number DEN250046 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 26, 2025
Decision Date August 19, 2026
Days to Decision 327 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 129d · This submission: 327d
Pathway characteristics

SIW Device Classification - Class ,

Product Code SIW
Device Class -