Cleared Traditional

K973727 - ELECTRODE, ELECTROCARDIOGRAPH

K973727 is an FDA 510(k) clearance for ELECTRODE, manufactured by Don Tay Industries. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K973727 · Don Tay Industries · Cardiovascular device
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Dec 1997
Decision
80d
Days
Class 2
Risk

K973727 is an FDA 510(k) clearance for the ELECTRODE, ELECTROCARDIOGRAPH. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Don Tay Industries (New Berlin, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 80 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 Don Tay Industries devices

FDA 510(k) Submission Details - K973727

510(k) Number K973727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1997
Decision Date December 19, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 153
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K973727.
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · 3M Healthcare · Jul 1998
PALJET-B
K973663 · Golden Gate Bio-Device · Feb 1998
NICAS(TM) ELECTRODE
K972001 · Ni Medical · Jul 1997
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444 · 3M Medical Products Group · Jun 1997
STEALTHSHIELD
K970755 · Vital Connections, Inc. · Apr 1997