Cleared Abbreviated

K090180 - TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE

K090180 is an FDA 510(k) clearance for TENDER-TRODE PREWIRED PEDIATRIC ECG ELE..., manufactured by Vermed, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Abbreviated 510(k) pathway after a 145-day FDA review.

K090180 · Vermed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
145d
Days
Class 2
Risk

K090180 is an FDA 510(k) clearance for the TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Vermed, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on June 17, 2009 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vermed, Inc. devices

FDA 510(k) Submission Details - K090180

510(k) Number K090180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2009
Decision Date June 17, 2009
Days to Decision 145 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Standards-based clearance path.

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 157
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K090180.
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
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K091856 · Conmed Corporation · Aug 2009
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SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
K080106 · Leonhard Lang GmbH · Feb 2008
SKINTACT AND VARIOUS OTHER TRADENAMES
K073104 · Leonhard Lang GmbH · Nov 2007