Cleared Traditional

K882414 - BLOOD RESERVOIR

K882414 is an FDA 510(k) clearance for BLOOD RESERVOIR, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 175-day FDA review.

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

FDA 510(k) Submission Details - K882414

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
Combination Product No
PCCP Authorized No
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.

DTN Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K882414.
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414 · Baxter Healthcare Corp · Jan 1990
CMS VRB-1200
K895076 · Cobe Laboratories, Inc. · Nov 1989
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · Shiley, Inc. · Jan 1989
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · Gish Biomedical, Inc. · Nov 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · Scimed Life Systems, Inc. · Oct 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345 · 3M Health Care, Sarns · Sep 1988