Cleared Traditional

SHILEY M2000 MEMBRANE OXYGENATOR (K833253) - FDA 510(k) Clearance

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

K833253 · Shiley, Inc. · Cardiovascular device
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Dec 1983
Decision
72d
Days
Class 2
Risk

K833253 is an FDA 510(k) clearance for the SHILEY M2000 MEMBRANE OXYGENATOR. 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 December 1, 1983 after a review of 72 days - a notably fast clearance cycle.

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: 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 K833253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1983
Decision Date December 01, 1983
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
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 K833253.
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
K853251 · Johnson & Johnson Professionals, Inc. · Oct 1985
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · C.R. Bard, Inc. · Oct 1985
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K833078 · Cordis Corp. · Jan 1984
BLOOD OXYGENATOR 5070
K831894 · Shiley, Inc. · Oct 1983
BLOOD OXYGENATOR 50 70/S
K831895 · Shiley, Inc. · Oct 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · C.R. Bard, Inc. · Jul 1983