Cleared Traditional

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 (K945065) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945065 · Sorin Biomedical, Inc. · Cardiovascular device
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May 1995
Decision
217d
Days
Class 2
Risk

K945065 is an FDA 510(k) clearance for the DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063. 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 19, 1995 after a review of 217 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 Sorin Biomedical, Inc. devices

Submission Details

510(k) Number K945065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date May 19, 1995
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 54
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K945065.
CAPIOX SX HARDSHELL RESERVOIR
K980935 · Terumo Medical Corp. · May 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155 · Baxter Healthcare Corp · Jan 1998
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713 · Baxter Healthcare Corp · Mar 1994
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · C.R. Bard, Inc. · Jun 1993
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573 · Baxter Healthcare Corp · Dec 1992