Cleared Traditional

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS (K944219) - FDA 510(k) Clearance

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

K944219 · Gish Biomedical, Inc. · Cardiovascular device
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Jun 1995
Decision
305d
Days
Class 2
Risk

K944219 is an FDA 510(k) clearance for the SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gish Biomedical, Inc. devices

Submission Details

510(k) Number K944219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date June 30, 1995
Days to Decision 305 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 125d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K944219.
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
K003724 · Medtronic Vascular · Dec 2000
CAPIOX CARDIOPLEGIA
K982467 · Terumo Medical Corp. · Jun 1999
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475 · Medtronic Vascular · Nov 1997
ROTATOR
K932251 · Merit Medical Systems, Inc. · Aug 1993
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742 · Medtronic Vascular · Dec 1991
MYOCARDIAL PROTECTION SYSTEM
K905500 · Medtronic Vascular · Jun 1991