Cleared Traditional

K990113 - DISPOSABLE ECG MONITORING ELECTRODES

K990113 is an FDA 510(k) clearance for DISPOSABLE ECG MONITORING ELECTRODES, manufactured by Maersk Medical A/S. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 327-day FDA review.

K990113 · Maersk Medical A/S · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
327d
Days
Class 2
Risk

K990113 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND.... Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Maersk Medical A/S (Fort Worth, US). The FDA issued a Cleared decision on December 6, 1999 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Maersk Medical A/S devices

FDA 510(k) Submission Details - K990113

510(k) Number K990113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1999
Decision Date December 06, 1999
Days to Decision 327 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 125d · This submission: 327d
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 97
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K990113.
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
AMBU DISPOSABLE ECG ELECTRODE
K041734 · Ambu, Inc. · Sep 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · Ambu, Inc. · Jun 2004
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997