Cleared Traditional

K895632 - SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380

K895632 is an FDA 510(k) clearance for SARNS MEMBRANE OXYGENATOR W/INTEGRAL CA..., manufactured by 3M Company. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K895632 · 3M Company · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
84d
Days
Class 2
Risk

K895632 is an FDA 510(k) clearance for the SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380. 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 12, 1989 after a review of 84 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.

FDA 510(k) Submission Details - K895632

510(k) Number K895632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1989
Decision Date December 12, 1989
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 253
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K895632.
CARDIOPULMONARY SUPPORT (CPS) SYSTEM
K892664 · Bard Cardiosurgery Div · Feb 1990
SAFE-1
K893704 · Polystan C/O Vitalcor, Inc. · Dec 1989
CLOSED CHEST SUPPORT CIRCUIT
K893207 · Medtronic Blood Systems, Inc. · Dec 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · 3M Company · Dec 1989
BARD WM HARVEY HF-5700 MEMB OXYGEN W/HARDSHELL RES
K892641 · Bard Cardiosurgery Div · Nov 1989
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K894970 · Minntech Corp. · Nov 1989
K895632 · SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
Download PDF 3M Company