Cleared Traditional

K883053 - SCIMED MEMBRANE OXYGENATOR

K883053 is the FDA 510(k) clearance for SCIMED MEMBRANE OXYGENATOR by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K883053 · Scimed Life Systems, Inc. · Cardiovascular device
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Sep 1988
Decision
69d
Days
Class 2
Risk

K883053 is an FDA 510(k) clearance for the SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 26, 1988 after a review of 69 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K883053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1988
Decision Date September 26, 1988
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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 191
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K883053.
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
K894630 · Shiley, Inc. · Oct 1989
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
K894103 · Scimed Life Systems, Inc. · Sep 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
K890808 · 3M Company · May 1989
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
K883054 · Scimed Life Systems, Inc. · Sep 1988
COBE CML3
K880021 · Cobe Laboratories, Inc. · Apr 1988
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K874841 · Bentley Laboratories, Inc. · Feb 1988