Cleared Traditional

BLOOD OXYGENATOR 5070 (K831894) - FDA 510(k) Clearance

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

K831894 · Shiley, Inc. · Cardiovascular device
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Oct 1983
Decision
128d
Days
Class 2
Risk

K831894 is an FDA 510(k) clearance for the BLOOD OXYGENATOR 5070. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Shiley, Inc. devices

Submission Details

510(k) Number K831894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date October 20, 1983
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 91
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K831894.
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · C.R. Bard, Inc. · Oct 1985
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K833078 · Cordis Corp. · Jan 1984
SHILEY M2000 MEMBRANE OXYGENATOR
K833253 · Shiley, Inc. · Dec 1983
BLOOD OXYGENATOR 50 70/S
K831895 · Shiley, Inc. · Oct 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · C.R. Bard, Inc. · Jul 1983
WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-
K831122 · C.R. Bard, Inc. · May 1983