Cleared Special

K982415 - CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210

K982415 is an FDA 510(k) clearance for CORDIS WEBSTER REF-STAR EXTERNAL REFERE..., manufactured by Cordis Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 28-day FDA review.

K982415 · Cordis Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
28d
Days
Class 2
Risk

K982415 is an FDA 510(k) clearance for the CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Cordis Webster, Inc. (Baldwin Park, US). The FDA issued a Cleared decision on August 10, 1998 after a review of 28 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K982415

510(k) Number K982415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date August 10, 1998
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DRF Device Classification - Class 2, Special Controls

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 180
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K982415.
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K982415 · CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
Download PDF FDA Summary Cordis Webster, Inc.