Cleared Special

K091856 - CONMED ECG MONITORING ELECTRODES

K091856 is the FDA 510(k) clearance for CONMED ECG MONITORING ELECTRODES by Conmed Corporation. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Special 510(k) pathway after a 45-day FDA review.

K091856 · Conmed Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
45d
Days
Class 2
Risk

K091856 is an FDA 510(k) clearance for the CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, .... Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 45 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Conmed Corporation devices

Submission Details

510(k) Number K091856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date August 07, 2009
Days to Decision 45 days
Submission Type Special
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
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 77
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K091856.
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K100129 · Ambu A/S · Jun 2010
AMBU WHITE SENSOR CFM, CFL
K052944 · Ambu A/S · Oct 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · Ambu A/S · Oct 2006
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998