Cleared Traditional

K894103 - SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST

K894103 is the FDA 510(k) clearance for SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K894103 · Scimed Life Systems, Inc. · Cardiovascular device
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Sep 1989
Decision
104d
Days
Class 2
Risk

K894103 is an FDA 510(k) clearance for the SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 21, 1989 after a review of 104 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K894103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date September 21, 1989
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K894103.
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · 3M Company · Dec 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · 3M Company · Dec 1989
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
K894630 · Shiley, Inc. · Oct 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV
K890808 · 3M Company · May 1989
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
K883053 · Scimed Life Systems, Inc. · Sep 1988
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
K883054 · Scimed Life Systems, Inc. · Sep 1988