Cleared Special

K042998 - REFSTAR RMT EXTERNAL REFERENCE PATCH

K042998 is the FDA 510(k) clearance for REFSTAR RMT EXTERNAL REFERENCE PATCH by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Special 510(k) pathway after a 332-day FDA review.

K042998 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
332d
Days
Class 2
Risk

K042998 is an FDA 510(k) clearance for the REFSTAR RMT EXTERNAL REFERENCE PATCH. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on September 29, 2005 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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. Elevated predicate reliance 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 Biosense Webster, Inc. devices

Submission Details

510(k) Number K042998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date September 29, 2005
Days to Decision 332 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
207d slower than avg
Panel avg: 125d · This submission: 332d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 96
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K042998.
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