Cleared Traditional

K925369 - BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

K925369 is an FDA 510(k) clearance for BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS, manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K925369 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
154d
Days
Class 2
Risk

K925369 is an FDA 510(k) clearance for the BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 1993 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 Biomedica, Fiat, USA, Inc. devices

FDA 510(k) Submission Details - K925369

510(k) Number K925369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1992
Decision Date March 26, 1993
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 83
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K925369.
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · Electromedics, Inc. · Dec 1993
ROTATOR
K932251 · Merit Medical Systems, Inc. · Aug 1993
HE-30 GOLD
K931967 · Bentley Laboratories, Inc. · Jul 1993
CONDUCER HEAT EXCHANGER
K923311 · 3M Health Care, Sarns · Sep 1992
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
K913077 · Dlp, Inc. · Jan 1992
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691 · Gish Biomedical, Inc. · Dec 1991