Cleared Traditional

K033800 - CAPIOX CARDIOTOMY RESERVOIR

K033800 is an FDA 510(k) clearance for CAPIOX CARDIOTOMY RESERVOIR, manufactured by Terumo Cardiovascular Systems Corporation. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K033800 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
67d
Days
Class 2
Risk

K033800 is an FDA 510(k) clearance for the CAPIOX CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on February 10, 2004 after a review of 67 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Cardiovascular Systems Corporation devices

FDA 510(k) Submission Details - K033800

510(k) Number K033800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2003
Decision Date February 10, 2004
Days to Decision 67 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K033800.
V-BAG WITH GBS COATING
K050195 · Gish Biomedical, Inc. · Mar 2005
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111 · Cobe Cardiovascular, Inc. · Mar 2005
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · Terumo Cardiovascular Systems Corp. · Mar 2004
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · Cobe Cardiovascular, Inc. · Dec 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
K033714 · Dideco S.P.A. · Dec 2003
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K031700 · Medtronic Perfusion Systems · Aug 2003