Cleared Special

K030264 - QUANDROX SAFELINE HOLLOW FIBER MEMBRANE...

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

K030264 · Jostra AG · Cardiovascular device
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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

Submission Details

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.

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 K030264.
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