Cleared Traditional

K941215 - VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR

K941215 is an FDA 510(k) clearance for VENOMIDICARD INFANT/ PEDIATRIC VENOUS C..., manufactured by Sorin Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K941215 · Sorin Biomedical, Inc. · Cardiovascular device
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May 1995
Decision
426d
Days
Class 2
Risk

K941215 is an FDA 510(k) clearance for the VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Sorin Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Sorin Biomedical, Inc. devices

FDA 510(k) Submission Details - K941215

510(k) Number K941215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1994
Decision Date May 10, 1995
Days to Decision 426 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 125d · This submission: 426d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K941215.
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821 · Minntech Corp. · Mar 1996
SOFT VENOUS RESERVOIR
K955046 · Gish Biomedical, Inc. · Jan 1996
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713 · Baxter Healthcare Corp · Mar 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · Gish Biomedical, Inc. · Feb 1994
EL2-SERIES BLOOD COLLECTION REERVOIR
K930154 · Electromedics, Inc. · Jul 1993