Cleared Traditional

K982817 - EWC: ECG CABLE AND LEADWIRE SYSTEMS

K982817 is an FDA 510(k) clearance for EWC: ECG CABLE AND LEADWIRE SYSTEMS, manufactured by Ewc. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K982817 · Ewc · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
43d
Days
Class 2
Risk

K982817 is an FDA 510(k) clearance for the EWC: ECG CABLE AND LEADWIRE SYSTEMS. 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 September 23, 1998 after a review of 43 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ewc devices

FDA 510(k) Submission Details - K982817

510(k) Number K982817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date September 23, 1998
Days to Decision 43 days
Submission Type Traditional
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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K982817.
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 II CABLE LEADWIRE SYSTEM
K984263 · Ewc · Feb 1999
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
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
K971968 · Remington Medical, Inc. · Jul 1997