Cleared Special

K083384 - THERMODILUTION CATHETER

K083384 is an FDA 510(k) clearance for THERMODILUTION CATHETER, manufactured by Biosensors Intl. Pte. , Ltd.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 414-day FDA review.

K083384 · Biosensors Intl. Pte. , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
414d
Days
Class 2
Risk

K083384 is an FDA 510(k) clearance for the THERMODILUTION CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Biosensors Intl. Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on January 5, 2010 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Biosensors Intl. Pte. , Ltd. devices

FDA 510(k) Submission Details - K083384

510(k) Number K083384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date January 05, 2010
Days to Decision 414 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 125d · This submission: 414d
Pathway characteristics
Modification to existing cleared device.

DQO Device Classification - Class 2, Special Controls

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 370
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