Cleared Traditional

K992631 - ACUNAV DIAGNOSTIC ULTRASOUND CATHETER

K992631 is an FDA 510(k) clearance for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER, manufactured by Acuson Corp.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K992631

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.

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 Radiology devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 411
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K992631.
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · Merit Medical Systems, Inc. · Mar 2000
MIKRO-TIP ANGIOGRAPHIC CATHETER
K993694 · Millar Instruments, Inc. · Mar 2000
PATHFINDER II ANGIOGRAPHIC CATHETER
K990173 · Maxxim Medical · Dec 1999
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