Cleared Traditional

K083148 - TELECTRODE WET GEL ECG ELECTRODE

K083148 is an FDA 510(k) clearance for TELECTRODE WET GEL ECG 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 14-day FDA review.

K083148 · Bio Protech, Inc. · Cardiovascular device
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Nov 2008
Decision
14d
Days
Class 2
Risk

K083148 is an FDA 510(k) clearance for the TELECTRODE WET GEL ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Woonju-Si, Gangwon-Do, KR). The FDA issued a Cleared decision on November 7, 2008 after a review of 14 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 - K083148

510(k) Number K083148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2008
Decision Date November 07, 2008
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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

Underwriters Laboratories, Inc.
JEFF D RONGERO

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 K083148.
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