Cleared Traditional

K832671 - CARDIOTOMY RESERVOIR-FILTER 050-108-050

K832671 is an FDA 510(k) clearance for CARDIOTOMY RESERVOIR-FILTER 050-108-050, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K832671 · Cobe Laboratories, Inc. · Cardiovascular device
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Dec 1983
Decision
140d
Days
Class 2
Risk

K832671 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR-FILTER 050-108-050. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 140 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K832671

510(k) Number K832671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1983
Decision Date December 27, 1983
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 140
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K832671.
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079 · C.R. Bard, Inc. · Apr 1984
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120
K834373 · American Bentley · Feb 1984
USE OF TWEEN 80 AS A WETTING AGENT ON
K832802 · American Bentley · Dec 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479 · C.R. Bard, Inc. · Dec 1983
VENOUS RESERVOIR
K832924 · Shiley, Inc. · Oct 1983
CARDIOPLEGIA RESERVOIR-#500926
K831966 · American Bentley · Aug 1983