DEN240075 - Prolystica Pass Thru Disinfectant Wipes (FDA 510(k) Clearance)

DEN240075 is an FDA 510(k) submission (not cleared) for the Prolystica Pass Thru Disinfectant Wipes.

Submitted by Steris (Mentor, US). The FDA issued a Not Cleared (DENG) decision on May 1, 2026 after a review of 505 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 505 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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