Cleared Traditional

EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR (K872721) - FDA 510(k) Clearance

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

K872721 · Shiley, Inc. · Cardiovascular device
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Sep 1987
Decision
75d
Days
Class 2
Risk

K872721 is an FDA 510(k) clearance for the EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on September 23, 1987 after a review of 75 days - a notably fast clearance cycle.

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: 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 K872721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1987
Decision Date September 23, 1987
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
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 50
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K872721.
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · Johnson & Johnson Professionals, Inc. · Nov 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · Shiley, Inc. · Sep 1987
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K872720 · Shiley, Inc. · Sep 1987
EXPANDED USE FOR SHILEY 3L CARDF PLUS
K872722 · Shiley, Inc. · Sep 1987
WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR
K872378 · C.R. Bard, Inc. · Sep 1987
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K864895 · Johnson & Johnson Professionals, Inc. · Feb 1987