Cleared Traditional

K925075 - SARNS TURBO MEMBRANE OXYGENA. W/INT. RE...

K925075 is an FDA 510(k) clearance for SARNS TURBO MEMBRANE OXYGENA. W/INT. RE..., 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 243-day FDA review.

K925075 · 3M Health Care, Sarns · Cardiovascular device
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Jun 1993
Decision
243d
Days
Class 2
Risk

K925075 is an FDA 510(k) clearance for the SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR. 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 June 7, 1993 after a review of 243 days - an extended review 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: 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 - K925075

510(k) Number K925075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date June 07, 1993
Days to Decision 243 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
118d slower than avg
Panel avg: 125d · This submission: 243d
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 K925075.
COBE CMS-FS MEMBRANE OXYGENATOR
K926467 · Cobe Cardiovascular, Inc. · Nov 1993
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · Terumo Medical Corp. · Sep 1993
INTERSEPT FILTERED CARDIOTOMY RESERVOIR
K926226 · Medtronic Vascular · Jun 1993
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
K925076 · 3M Health Care, Sarns · Jun 1993
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
K923272 · Cobe Laboratories, Inc. · May 1993
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K925626 · Medtronic Vascular · Feb 1993