Cleared Traditional

K896671 - SARNS MEMBRANE OXYGENATOR W/INTEGRAL RE...

K896671 is the FDA 510(k) clearance for SARNS MEMBRANE OXYGENATOR W/INTEGRAL RE... by 3M Company. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K896671 · 3M Company · Cardiovascular device
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Feb 1990
Decision
79d
Days
Class 2
Risk

K896671 is an FDA 510(k) clearance for the SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461. 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 February 14, 1990 after a review of 79 days - a notably fast clearance cycle.

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: 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 Company devices

Submission Details

510(k) Number K896671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date February 14, 1990
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 K896671.
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901250 · Shiley, Inc. · Jun 1990
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
K894826 · Bentley Laboratories, Inc. · Feb 1990
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
K896978 · Medtronic Vascular · Feb 1990
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