Cleared Traditional

SHILEY VENOUS RESERVOIR (K842337) - FDA 510(k) Clearance

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

K842337 · Shiley, Inc. · Cardiovascular device
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Aug 1984
Decision
73d
Days
Class 2
Risk

K842337 is an FDA 510(k) clearance for the SHILEY VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 73 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 K842337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date August 17, 1984
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K842337.
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · C.R. Bard, Inc. · Sep 1986
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · Shiley, Inc. · Jan 1985
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