Cleared Traditional

K151713 - LILLIPUP PMP

K151713 is the FDA 510(k) clearance for LILLIPUP PMP by Sorin Group Italia S.R.L.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K151713 · Sorin Group Italia S.R.L. · Cardiovascular device
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Nov 2015
Decision
134d
Days
Class 2
Risk

K151713 is an FDA 510(k) clearance for the LILLIPUP PMP, LILLIPUT PMP INTEGRATED. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on November 6, 2015 after a review of 134 days - within the typical 510(k) review window.

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 Sorin Group Italia S.R.L. devices

Submission Details

510(k) Number K151713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2015
Decision Date November 06, 2015
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Parexel Consulting, LLC
BARRY S. SALL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 162
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K151713.
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
K172626 · Medtronic, Inc. · Oct 2017
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · Medtronic, Inc. · Dec 2016
Affinity NT Oxygenator with Cortiva BioActive Surface
K162016 · Medtronic, Inc. · Sep 2016
EOS PMP, EOS PMP Integrated
K150489 · Sorin Group Italia S.R.L. · Jun 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
K143073 · Medtronic, Inc. · Mar 2015
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
K142784 · Medtronic, Inc. · Oct 2014