Cleared Traditional

K013038 - SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010

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

K013038 · Polystan A/S · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K013038

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.

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 236
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K013038.
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
K023381 · Gish Biomedical, Inc. · Mar 2003
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
K022450 · Dideco S.P.A. · Oct 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
K022115 · Terumo Corp. · Sep 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · Dideco S.P.A. · Apr 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · Dideco S.P.A. · Feb 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · Dideco S.P.A. · Jan 2002