Cleared Traditional

K102919 - NEONATAL VENOUS HARDSHELL CARDIOTOMY RE...

K102919 is the FDA 510(k) clearance for NEONATAL VENOUS HARDSHELL CARDIOTOMY RE... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K102919 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Mar 2011
Decision
161d
Days
Class 2
Risk

K102919 is an FDA 510(k) clearance for the NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CA.... Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on March 11, 2011 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K102919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date March 11, 2011
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 120
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K102919.
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K122914 · Medtronic, Inc. · Jan 2013
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K112771 · Sorin Group Italia S.R.L. · Oct 2011
XRES BLOOD COLLECTION RESERVOIR
K100507 · Sorin Group Italia S.R.L. · Mar 2010
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
K090534 · Maquet Cardiopulmonary, AG · Dec 2009
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
K090690 · Maquet Cardiopulmonary, AG · Dec 2009