Cleared Traditional

K992631 - ACUNAV DIAGNOSTIC ULTRASOUND CATHETER

K992631 is the FDA 510(k) clearance for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER by Acuson Corp.. It is a Class 2 Radiology device (product code DQO) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K992631 · Acuson Corp. · Radiology device
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Dec 1999
Decision
131d
Days
Class 2
Risk

K992631 is an FDA 510(k) clearance for the ACUNAV DIAGNOSTIC ULTRASOUND CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Acuson Corp. (Washington, US). The FDA issued a Cleared decision on December 15, 1999 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acuson Corp. devices

Submission Details

510(k) Number K992631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date December 15, 1999
Days to Decision 131 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 107d · This submission: 131d
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 Radiology devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 295
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K992631.
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · Cordis Corp. · May 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956 · Boston Scientific Scimed, Inc. · Apr 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · Merit Medical Systems, Inc. · Mar 2000
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · Cordis Corp. · Oct 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · Boston Scientific Scimed, Inc. · Aug 1999
RADIFOCUS OPTITORQUE
K992051 · Terumo Medical Corp. · Aug 1999