Cleared Traditional

K013038 - SAFE MAXI HOLLOW FIBER OXYGENATOR

K013038 is the FDA 510(k) clearance for SAFE MAXI HOLLOW FIBER OXYGENATOR by Polystan A/S. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K013038 · Polystan A/S · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
338d
Days
Class 2
Risk

K013038 is an FDA 510(k) clearance for the SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Polystan A/S (Vaerlose, DK). The FDA issued a Cleared decision on August 14, 2002 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Polystan A/S devices

Submission Details

510(k) Number K013038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2001
Decision Date August 14, 2002
Days to Decision 338 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 125d · This submission: 338d
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 192
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K013038.
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
K061031 · Sorin Group Italia S.R.L. · Jun 2006
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K051997 · Terumo Cardiovascular Systems Corp. · Sep 2005
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
K023381 · Gish Biomedical, Inc. · Mar 2003
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
K010443 · Terumo Cardiovascular Systems Corp. · Dec 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · Cobe Cardiovascular, Inc. · Nov 2001
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
K993772 · Terumo Medical Corp. · Jun 2000