Cleared Traditional

K062760 - ORI F6T DRY ECG MONITORING ELECTRODE

K062760 is an FDA 510(k) clearance for ORI F6T DRY ECG MONITORING ELECTRODE, manufactured by Orbital Research, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K062760 · Orbital Research, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
87d
Days
Class 2
Risk

K062760 is an FDA 510(k) clearance for the ORI F6T DRY ECG MONITORING ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Orbital Research, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 87 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 Orbital Research, Inc. devices

FDA 510(k) Submission Details - K062760

510(k) Number K062760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2006
Decision Date December 11, 2006
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 174
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K062760.
TELECTRODE WET GEL ECG ELECTRODE
K083148 · Bio Protech, Inc. · Nov 2008
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
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