Cleared Special

K030073 - VERMED A10021 RESTING EKG TAB ELECTRODE

K030073 is an FDA 510(k) clearance for VERMED A10021 RESTING EKG TAB ELECTRODE, manufactured by Vermont Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Special 510(k) pathway after a 79-day FDA review.

K030073 · Vermont Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
79d
Days
Class 2
Risk

K030073 is an FDA 510(k) clearance for the VERMED A10021 RESTING EKG TAB ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Vermont Medical, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on March 28, 2003 after a review of 79 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 Vermont Medical, Inc. devices

FDA 510(k) Submission Details - K030073

510(k) Number K030073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2003
Decision Date March 28, 2003
Days to Decision 79 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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 176
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K030073.
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · Ambu, Inc. · Jun 2004
PROTAB ECG TABB ELECTRODE
K040784 · Bio Protech, Inc. · Apr 2004
SKINTACT ECG ELECTRODE
K040249 · Leonhard Lang GmbH · Feb 2004
SKINTACT ECG TAB ELECTRODE
K030509 · Leonhard Lang GmbH · Mar 2003
SKINTACT
K023920 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003