Cleared Traditional

K821216 - INTERPULSE MEMBRANE OXYGENATOR

K821216 is the FDA 510(k) clearance for INTERPULSE MEMBRANE OXYGENATOR by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K821216 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
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Jun 1982
Decision
36d
Days
Class 2
Risk

K821216 is an FDA 510(k) clearance for the INTERPULSE MEMBRANE OXYGENATOR. 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 June 2, 1982 after a review of 36 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 K821216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date June 02, 1982
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 K821216.
OXYGENATOR 10
K823343 · Gambro, Inc. · Dec 1982
CAPIOX II
K823125 · Terumo Medical Corp. · Nov 1982
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD
K821477 · C.R. Bard, Inc. · Nov 1982
LPM/50 MEMBRANE OXYGENATOR
K813255 · Travenol Laboratories, S.A. · Jan 1982
TERUMO HOLLOW FIBER OXYGENATOR
K812660 · Terumo Medical Corp. · Dec 1981
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · Cobe Laboratories, Inc. · Apr 1981