Cleared Traditional

K202206 - AMG PMP Pediatric

K202206 is an FDA 510(k) clearance for AMG PMP Pediatric, manufactured by Eurosets S.R.L. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K202206 · Eurosets S.R.L · Cardiovascular device
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Apr 2021
Decision
239d
Days
Class 2
Risk

K202206 is an FDA 510(k) clearance for the AMG PMP Pediatric. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Eurosets S.R.L (Medolla, IT). The FDA issued a Cleared decision on April 1, 2021 after a review of 239 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Eurosets S.R.L devices

FDA 510(k) Submission Details - K202206

510(k) Number K202206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2020
Decision Date April 01, 2021
Days to Decision 239 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 125d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K202206.
AMG PMP Infant
K202510 · Eurosets S.R.L · Dec 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · Medtronic · Sep 2021
EOS PMP
K211495 · Sorin Group Italia S.R.L. · Jul 2021
OXY-1 System
K200109 · Abiomed, Inc. · Oct 2020
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
K201642 · Chalice Medical , Ltd. · Sep 2020
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
K201916 · Sorin Group Italia S.R.L. · Aug 2020