Cleared Traditional

K030505 - CAPIOX CARDIOTOMY RESERVOIR

K030505 is an FDA 510(k) clearance for CAPIOX CARDIOTOMY RESERVOIR, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K030505 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
84d
Days
Class 2
Risk

K030505 is an FDA 510(k) clearance for the CAPIOX CARDIOTOMY RESERVOIR. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on May 14, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Corp. devices

FDA 510(k) Submission Details - K030505

510(k) Number K030505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date May 14, 2003
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 34
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