Cleared Traditional

K073474 - CAPIOX CIRCUIT CONNECTORS

K073474 is an FDA 510(k) clearance for CAPIOX CIRCUIT CONNECTORS, manufactured by Terumo Corp.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K073474 · Terumo Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2008
Decision
85d
Days
Class 2
Risk

K073474 is an FDA 510(k) clearance for the CAPIOX CIRCUIT CONNECTORS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on March 5, 2008 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Corp. devices

FDA 510(k) Submission Details - K073474

510(k) Number K073474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2007
Decision Date March 05, 2008
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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