Cleared Traditional

K863902 - MODIFIED SARNS MEMBRANE OXYGENATOR

K863902 is an FDA 510(k) clearance for MODIFIED SARNS MEMBRANE OXYGENATOR, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTX cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K863902 · 3M Health Care, Sarns · Cardiovascular device
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Dec 1986
Decision
65d
Days
Class 2
Risk

K863902 is an FDA 510(k) clearance for the MODIFIED SARNS MEMBRANE OXYGENATOR. Classified as Gas Control Unit, Cardiopulmonary Bypass (product code DTX), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on December 11, 1986 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4300 - 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K863902

510(k) Number K863902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1986
Decision Date December 11, 1986
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTX Device Classification - Class 2, Special Controls

Product Code DTX Gas Control Unit, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4300
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 - DTX Gas Control Unit, Cardiopulmonary Bypass

All 9
Devices cleared under the same product code (DTX) and FDA review panel - the closest regulatory comparables to K863902.
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
K101046 · Sorin Group Deutschland GmbH · Dec 2010
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745 · Sechrist Industries, Inc. · Jan 2003
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
K965214 · Coeur Laboratories, Inc. · Mar 1997
GAS-FLOW METER GFL 10
K822820 · Gambro, Inc. · Oct 1982
STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
K792348 · Cordis Corp. · Dec 1979
FLOWMETER, OPTIFLO GAS
K790546 · Cobe Laboratories, Inc. · May 1979