Cleared Traditional

K022004 - CARDIAC OUTPUT KIT

K022004 is the FDA 510(k) clearance for CARDIAC OUTPUT KIT by Biosensors International-USA. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K022004 · Biosensors International-USA · Cardiovascular device
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Mar 2003
Decision
266d
Days
Class 2
Risk

K022004 is an FDA 510(k) clearance for the CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Biosensors International-USA (Newport Beach, US). The FDA issued a Cleared decision on March 12, 2003 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosensors International-USA devices

Submission Details

510(k) Number K022004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2002
Decision Date March 12, 2003
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K022004.
PROGREAT
K033583 · Terumo Medical Corp. · Dec 2003
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K032376 · AngioDynamics, Inc. · Aug 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · Deroyal Industries, Inc. · Jun 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · Abbott Laboratories · Jan 2003
RENEGADE STC 18 MICROCATHETER
K023681 · Boston Scientific Corp · Nov 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · Boston Scientific Corp · Sep 2002