Cleared Traditional

K912078 - SARNS SM03 MEMBRANE OXYGENATOR

K912078 is an FDA 510(k) clearance for SARNS SM03 MEMBRANE OXYGENATOR, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K912078 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
102d
Days
Class 2
Risk

K912078 is an FDA 510(k) clearance for the SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on August 20, 1991 after a review of 102 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 Health Care, Sarns devices

FDA 510(k) Submission Details - K912078

510(k) Number K912078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date August 20, 1991
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
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 201
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K912078.
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · 3M Health Care, Ltd. · Sep 1991
MINIMAX OXYGENATION SYSTEM
K912655 · Medtronic Vascular · Sep 1991
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
K897068 · Medtronic Vascular · Aug 1991
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
K911227 · 3M Health Care, Sarns · May 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · Baxter Healthcare Corp · Apr 1991
SARNS MEMBRANE OXGENATOR PART NUMBER 9443
K903436 · 3M Health Care, Sarns · Oct 1990