Cleared Abbreviated

K984263 - EWC: ECG II CABLE LEADWIRE SYSTEM

K984263 is an FDA 510(k) clearance for EWC: ECG II CABLE LEADWIRE SYSTEM, manufactured by Ewc. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Abbreviated 510(k) pathway after a 64-day FDA review.

K984263 · Ewc · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
64d
Days
Class 2
Risk

K984263 is an FDA 510(k) clearance for the EWC: ECG II CABLE LEADWIRE SYSTEM. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Ewc (Pewaukee, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ewc devices

FDA 510(k) Submission Details - K984263

510(k) Number K984263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1998
Decision Date February 02, 1999
Days to Decision 64 days
Submission Type Abbreviated
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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Standards-based clearance path.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 66
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K984263.
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
K012392 · Pace Medical · Sep 2001
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · Biosense Webster, Inc. · Jul 2000
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
K992524 · Advantage Medical Electronics, Inc. · Mar 2000
EWC: ECG CABLE AND LEADWIRE SYSTEMS
K982817 · Ewc · Sep 1998
AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · Affinity Medical Technologies, LLC · Mar 1998
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
K980582 · Marquette Medical Systems, Inc. · Mar 1998