Cleared Traditional

SHILEY 3L CARDF PLUS (K832811) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832811 · Shiley, Inc. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Sep 1983

Decision

33d

Days

Class 2

Risk

K832811 is an FDA 510(k) clearance for the SHILEY 3L CARDF PLUS. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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 Shiley, Inc. devices

Submission Details

510(k) Number	K832811 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1983
Decision Date	September 20, 1983
Days to Decision	33 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

92d faster than avg

Panel avg: 125d · This submission: 33d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DTP Defoamer, Cardiopulmonary Bypass
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.4230

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 - DTP Defoamer, Cardiopulmonary Bypass

All 12

Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K832811.

BARD FILTERED CARDIOTOMY RESERVOIR

K902856 · C.R. Bard, Inc. · Sep 1990

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

K902355 · Medtronic Vascular · Aug 1990

SHILEY 3L CARDIOTOMY RESERVOIR

K853503 · Shiley, Inc. · Nov 1985

CARDF

K823731 · Shiley, Inc. · Jan 1983

CAPIOX CR-CARDIOTOMY RESERVOIR

K821538 · Terumo Medical Corp. · Aug 1982

CARDIOTOMY RESERVOIR WITH FILTER

K801360 · Travenol Laboratories, S.A. · Jul 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832811

Shiley, Inc.

Walker, MI · US

Regulatory profile

174 submissions 174 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active