Cleared Traditional

K895076 - CMS VRB-1200

K895076 is the FDA 510(k) clearance for CMS VRB-1200 by Cobe Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K895076 · Cobe Laboratories, Inc. · Cardiovascular device
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Nov 1989
Decision
81d
Days
Class 2
Risk

K895076 is an FDA 510(k) clearance for the CMS VRB-1200. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 3, 1989 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K895076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1989
Decision Date November 03, 1989
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
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 75
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K895076.
UNIVOX-IC
K895356 · Baxter Healthcare Corp · Mar 1990
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
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · Gish Biomedical, Inc. · Dec 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · Gish Biomedical, Inc. · Nov 1988