Cleared Traditional

CARDIOTOMY RESERVOIR BRS-XXX SERIES & (K843888) - FDA 510(k) Clearance

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

K843888 · Gish Biomedical, Inc. · Cardiovascular device
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Feb 1985
Decision
135d
Days
Class 2
Risk

K843888 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR BRS-XXX SERIES &. 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 February 14, 1985 after a review of 135 days - within the typical 510(k) review window.

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 K843888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date February 14, 1985
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
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 K843888.
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K864895 · Johnson & Johnson Professionals, Inc. · Feb 1987
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · C.R. Bard, Inc. · Sep 1986
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · Shiley, Inc. · Jan 1985
SHILEY VENOUS RESERVOIR
K842337 · Shiley, Inc. · Aug 1984
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K842711 · Shiley, Inc. · Aug 1984