Cleared Traditional

K832802 - USE OF TWEEN 80 AS A WETTING AGENT ON

K832802 is an FDA 510(k) clearance for USE OF TWEEN 80 AS A WETTING AGENT ON, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K832802

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.

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 143
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K832802.
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 RESERVORS BCR-3000/3500-Q-120
K834373 · American Bentley · Feb 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