Cleared Traditional

K832811 - SHILEY 3L CARDF PLUS

K832811 is an FDA 510(k) clearance for SHILEY 3L CARDF PLUS, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K832811 · Shiley, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K832811

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.

DTP Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K832811.
VENOUS RESERVOIR-BMR-1500-HARD SHELL
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SCIMED MODEL SC4000
K840610 · Scimed Life Systems, Inc. · Apr 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · Scimed Life Systems, Inc. · Jan 1984
CARDF
K823731 · Shiley, Inc. · Jan 1983
CAPIOX CR-CARDIOTOMY RESERVOIR
K821538 · Terumo Medical Corp. · Aug 1982
SCIMED MODEL SC 3000
K820954 · Scimed Life Systems, Inc. · May 1982