Cleared Traditional

K803003 - INTERPULSE MEMBRANE OXYGENATION SYSTEM

K803003 is the FDA 510(k) clearance for INTERPULSE MEMBRANE OXYGENATION SYSTEM by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K803003 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
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Jan 1981
Decision
57d
Days
Class 2
Risk

K803003 is an FDA 510(k) clearance for the INTERPULSE MEMBRANE OXYGENATION SYSTEM. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1981 after a review of 57 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K803003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1980
Decision Date January 22, 1981
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 122
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K803003.
TERUMO HOLLOW FIBER OXYGENATOR
K812660 · Terumo Medical Corp. · Dec 1981
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · Cobe Laboratories, Inc. · Apr 1981
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
K810470 · Shiley, Inc. · Apr 1981
THB 6000 HARDSHELL BUBBLE OXYGENATOR
K803231 · Travenol Laboratories, S.A. · Jan 1981
WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
K792039 · C.R. Bard, Inc. · Oct 1979
OXYGENATOR, COBE CATALOG #42-220
K790356 · Cobe Laboratories, Inc. · Mar 1979