Cleared Traditional

K040784 - PROTAB ECG TABB ELECTRODE

K040784 is an FDA 510(k) clearance for PROTAB ECG TABB ELECTRODE, manufactured by Bio Protech, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K040784 · Bio Protech, Inc. · Cardiovascular device
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Apr 2004
Decision
9d
Days
Class 2
Risk

K040784 is an FDA 510(k) clearance for the PROTAB ECG TABB ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 9 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 Bio Protech, Inc. devices

FDA 510(k) Submission Details - K040784

510(k) Number K040784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date April 07, 2004
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 179
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K040784.
AMBU DISPOSABLE ECG ELECTRODE
K041734 · Ambu, Inc. · Sep 2004
DISPOSABLE MONITORING ELECTRODES
K041954 · Shanghai Intco Electrode Manufacturing Co., Ltd. · Sep 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · Ambu, Inc. · Jun 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