Cleared Traditional

K803179 - DISPOSABLE ELECTRODE FOR EKG

K803179 is an FDA 510(k) clearance for DISPOSABLE ELECTRODE FOR EKG, manufactured by Midwest Monitoring. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K803179 · Midwest Monitoring · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
85d
Days
Class 2
Risk

K803179 is an FDA 510(k) clearance for the DISPOSABLE ELECTRODE FOR EKG. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Midwest Monitoring (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Midwest Monitoring devices

FDA 510(k) Submission Details - K803179

510(k) Number K803179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1980
Decision Date March 11, 1981
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 198
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K803179.
THE NEW 1600 ELECTRODE
K812878 · Andover Medical, Inc. · Nov 1981
DISPOSABLE ELECTRODE, #1610
K812276 · Andover Medical, Inc. · Sep 1981
QUINTON LTE ELECTRODE
K810563 · Quinton, Inc. · Mar 1981
INFANT ECG ELECTRODE #60-1029
K810102 · Aspen Laboratories, Inc. · Jan 1981
ADULT ECG ELECTRODE #60-0724
K810103 · Aspen Laboratories, Inc. · Jan 1981
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · C.R. Bard, Inc. · Nov 1979