Cleared Special

K030264 - QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030

K030264 is an FDA 510(k) clearance for QUANDROX SAFELINE HOLLOW FIBER MEMBRANE..., manufactured by Jostra AG. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 30-day FDA review.

K030264 · Jostra AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
30d
Days
Class 2
Risk

K030264 is an FDA 510(k) clearance for the QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Jostra AG (Hirrlingen, DE). The FDA issued a Cleared decision on February 26, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jostra AG devices

FDA 510(k) Submission Details - K030264

510(k) Number K030264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date February 26, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 237
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K030264.
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
K033323 · Dideco S.P.A. · Jan 2004
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · Dideco S.P.A. · May 2003
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