Cleared Special

K990494 - MODIFICATION OF NOGA

K990494 is an FDA 510(k) clearance for MODIFICATION OF NOGA, manufactured by Biosense, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 198-day FDA review.

K990494 · Biosense, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
198d
Days
Class 2
Risk

K990494 is an FDA 510(k) clearance for the MODIFICATION OF NOGA. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990494

510(k) Number K990494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1999
Decision Date September 03, 1999
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 437
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K990494.
SYNEFLASH & SYNEVIEW
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K990956 · Biosensor Corp. · Jun 1999
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
K983102 · Cambridge Heart, Inc. · Apr 1999
MT-200
K973751 · Schiller America, Inc. · Aug 1998
K990494 · MODIFICATION OF NOGA
Download PDF FDA Summary Biosense, Inc.