Cleared Traditional

K895393 - SARNS INGANT MEMBRANE OXYGENATOR

K895393 is the FDA 510(k) clearance for SARNS INGANT MEMBRANE OXYGENATOR by 3M Company. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K895393 · 3M Company · Cardiovascular device
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Dec 1989
Decision
90d
Days
Class 2
Risk

K895393 is an FDA 510(k) clearance for the SARNS INGANT MEMBRANE OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by 3M Company (Ann Arbor, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 90 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 3M Company devices

Submission Details

510(k) Number K895393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date December 04, 1989
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K895393.
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
K896978 · Medtronic Vascular · Feb 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
K896671 · 3M Company · Feb 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · 3M Company · Dec 1989
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