Cleared Traditional

K896807 - SPBC SERIES SINGLE PASS BLOOD CARDIOPLE...

K896807 is an FDA 510(k) clearance for SPBC SERIES SINGLE PASS BLOOD CARDIOPLE..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K896807 · Gish Biomedical, Inc. · Cardiovascular device
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Jul 1990
Decision
239d
Days
Class 2
Risk

K896807 is an FDA 510(k) clearance for the SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 239 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K896807

510(k) Number K896807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date July 31, 1990
Days to Decision 239 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 125d · This submission: 239d
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 82
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K896807.
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742 · Medtronic Vascular · Dec 1991
MYOCARDIAL PROTECTION SYSTEM
K905500 · Medtronic Vascular · Jun 1991
BCD ADVANCED
K910923 · Shiley, Inc. · Apr 1991
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · Gish Biomedical, Inc. · May 1990
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640 · 3M Company · Apr 1990
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
K897039 · 3M Company · Mar 1990