Cleared Special

K013480 - COBE SMARXT OPTIMIN SURFACE MODIFIED HO...

K013480 is an FDA 510(k) clearance for COBE SMARXT OPTIMIN SURFACE MODIFIED HO..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K013480 · Cobe Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
28d
Days
Class 2
Risk

K013480 is an FDA 510(k) clearance for the COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 28 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K013480

510(k) Number K013480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date November 16, 2001
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K013480.
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
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
K993772 · Terumo Medical Corp. · Jun 2000
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K000255 · Cobe Cardiovascular, Inc. · Apr 2000
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
K000430 · Medtronic Vascular · Feb 2000