Cleared Traditional

K941653 - SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION

K941653 is an FDA 510(k) clearance for SARNS TURBO MEMBRANE OXYGENATOR MODIFIC..., 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 141-day FDA review.

K941653 · 3M Health Care, Sarns · Cardiovascular device
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Aug 1994
Decision
141d
Days
Class 2
Risk

K941653 is an FDA 510(k) clearance for the SARNS TURBO 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 24, 1994 after a review of 141 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 - K941653

510(k) Number K941653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date August 24, 1994
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
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 220
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K941653.
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
K961000 · Terumo Medical Corp. · Oct 1996
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
K951247 · Baxter Healthcare Corp · Nov 1995
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K941473 · Medtronic Vascular · Jun 1995
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
K941225 · Baxter Healthcare Corp · Aug 1994
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K934292 · Minntech Corp. · Jul 1994
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
K931444 · Sorin Biomedica, Fiat, USA, Inc. · May 1994