Cleared Traditional

K832802 - USE OF TWEEN 80 AS A WETTING AGENT ON

K832802 is the FDA 510(k) clearance for USE OF TWEEN 80 AS A WETTING AGENT ON by American Bentley. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K832802 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
133d
Days
Class 2
Risk

K832802 is an FDA 510(k) clearance for the USE OF TWEEN 80 AS A WETTING AGENT ON. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by American Bentley (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 133 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 American Bentley devices

Submission Details

510(k) Number K832802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date December 29, 1983
Days to Decision 133 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 125d · This submission: 133d
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 78
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K832802.
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K842711 · Shiley, Inc. · Aug 1984
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K841175 · C.R. Bard, Inc. · Apr 1984
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079 · C.R. Bard, Inc. · Apr 1984
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K832671 · Cobe Laboratories, Inc. · Dec 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479 · C.R. Bard, Inc. · Dec 1983
VENOUS RESERVOIR
K832924 · Shiley, Inc. · Oct 1983