Cleared Traditional

K843956 - SCIMED II MEMBRANE OXYGENATOR SYSTEM

K843956 is the FDA 510(k) clearance for SCIMED II MEMBRANE OXYGENATOR SYSTEM by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K843956 · Scimed Life Systems, Inc. · Cardiovascular device
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Jan 1985
Decision
91d
Days
Class 2
Risk

K843956 is an FDA 510(k) clearance for the SCIMED II MEMBRANE OXYGENATOR SYSTEM. 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 January 8, 1985 after a review of 91 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 K843956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date January 08, 1985
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K843956.
BLOOD OXYGENATOR MODEL NO. MAX-5
K850630 · American Bentley · Mar 1985
AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH
K844901 · American Bentley · Mar 1985
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · Cobe Laboratories, Inc. · Feb 1985
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
K843955 · Extracorporeal Medical Specialities, Inc. · Nov 1984
TUBULAR HOLLOW FIBER MEMBRANE
K841476 · American Bentley · Aug 1984
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K833078 · Cordis Corp. · Jan 1984