Cleared Traditional

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

K242503 · Eurosets Srl · Cardiovascular
Nov 2025
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K242503 is an FDA 510(k) clearance for the Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232), a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Eurosets Srl (Medolla, IT). The FDA issued a Cleared decision on November 24, 2025, 459 days after receiving the submission on August 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K242503 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2024
Decision Date November 24, 2025
Days to Decision 459 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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