Cleared Traditional

K090698 - CAPIOX BUBBLE TRAP WITH X-COATING

K090698 is the FDA 510(k) clearance for CAPIOX BUBBLE TRAP WITH X-COATING by Terumo Cardiovascular Systems. It is a Class 2 Cardiovascular device (product code KRL) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K090698 · Terumo Cardiovascular Systems · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2009
Decision
83d
Days
Class 2
Risk

K090698 is an FDA 510(k) clearance for the CAPIOX BUBBLE TRAP WITH X-COATING. Classified as Detector, Bubble, Cardiopulmonary Bypass (product code KRL), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems (Elkton, US). The FDA issued a Cleared decision on June 8, 2009 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4205 - 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 devices

Submission Details

510(k) Number K090698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2009
Decision Date June 08, 2009
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRL Detector, Bubble, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4205
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 - KRL Detector, Bubble, Cardiopulmonary Bypass

Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K090698.
SARNS ULTRASONIC AIR SENSOR
K940651 · 3M Health Care, Sarns · May 1994
SARNS AIR DETECTION SYSTEM
K935977 · 3M Health Care, Sarns · Feb 1994
CAPIOX(R) BUBBLE TRAP
K911632 · Terumo Medical Corp. · Jul 1991
CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
K864619 · Shiley, Inc. · Feb 1987
COBE ACCESSORY INTERFACE MODULE (AIM)
K861860 · Cobe Laboratories, Inc. · Jul 1986
COBE AEPS
K842054 · Cobe Laboratories, Inc. · Aug 1984