Cleared Traditional

K802890 - CPS-1000

K802890 is the FDA 510(k) clearance for CPS-1000 by Gics Pharmaceuticals. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K802890 · Gics Pharmaceuticals · Cardiovascular device
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Mar 1981
Decision
108d
Days
Class 2
Risk

K802890 is an FDA 510(k) clearance for the CPS-1000. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Gics Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 108 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 Gics Pharmaceuticals devices

Submission Details

510(k) Number K802890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date March 05, 1981
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 133
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K802890.
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455 · Electromedics, Inc. · Oct 1981
CORDIOTOMY RESERVOIR
K812008 · Bentley Laboratories, Inc. · Jul 1981
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K812009 · Bentley Laboratories, Inc. · Jul 1981
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K803059 · Extracorporeal Medical Specialities, Inc. · Dec 1980
SHILEY UTILITY RESERVOIR
K802119 · Shiley, Inc. · Sep 1980
Q220F CARDITOMY RESERVOIR/MODIFIED
K790635 · Bentley Laboratories, Inc. · Apr 1979