Cleared Special

K992051 - RADIFOCUS OPTITORQUE

K992051 is an FDA 510(k) clearance for RADIFOCUS OPTITORQUE, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 53-day FDA review.

K992051 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
53d
Days
Class 2
Risk

K992051 is an FDA 510(k) clearance for the RADIFOCUS OPTITORQUE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 53 days - a notably fast clearance cycle.

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: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Terumo Medical Corp. devices

FDA 510(k) Submission Details - K992051

510(k) Number K992051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date August 10, 1999
Days to Decision 53 days
Submission Type Special
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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K992051.
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CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · Cordis Corp. · May 1999
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · Daig Corp. · Oct 1998
ENVY GUIDING CATHETER
K974774 · Cook, Inc. · Oct 1998