Cleared Traditional

K843956 - SCIMED II MEMBRANE OXYGENATOR SYSTEM

K843956 is an FDA 510(k) clearance for SCIMED II MEMBRANE OXYGENATOR SYSTEM, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K843956

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.

DTZ Device Classification - Class 2, Special Controls

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 235
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