Cleared Traditional

BLOOD RESERVOIR, CARDIOPULMONARY BYPASS (K882414) - FDA 510(k) Clearance

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

K882414 · Gish Biomedical, Inc. · Cardiovascular device
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Dec 1988
Decision
175d
Days
Class 2
Risk

K882414 is an FDA 510(k) clearance for the BLOOD RESERVOIR, CARDIOPULMONARY BYPASS. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 175 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 Gish Biomedical, Inc. devices

Submission Details

510(k) Number K882414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1988
Decision Date December 05, 1988
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
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 51
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K882414.
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711 · Shiley, Inc. · Feb 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414 · Baxter Healthcare Corp · Jan 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · Shiley, Inc. · Jan 1989
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · Johnson & Johnson Professionals, Inc. · Nov 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · Shiley, Inc. · Sep 1987
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K872720 · Shiley, Inc. · Sep 1987