Cleared Special

K030449 - MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR

K030449 is an FDA 510(k) clearance for MODIFICATION TO CAPIOX SX10 HARDSHELL R..., manufactured by Terumo Corp.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Special 510(k) pathway after a 22-day FDA review.

K030449 · Terumo Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
22d
Days
Class 2
Risk

K030449 is an FDA 510(k) clearance for the MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on March 5, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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.

FDA 510(k) Submission Details - K030449

510(k) Number K030449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date March 05, 2003
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 167
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K030449.
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K013526 · Terumo Cardiovascular Systems Corp. · Nov 2001
K030449 · MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
Download PDF FDA Summary Terumo Corp.