Cleared Traditional

K041954 - DISPOSABLE MONITORING ELECTRODES

K041954 is an FDA 510(k) clearance for DISPOSABLE MONITORING ELECTRODES, manufactured by Shanghai Intco Electrode Manufacturing Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K041954 · Shanghai Intco Electrode Manufacturing Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
57d
Days
Class 2
Risk

K041954 is an FDA 510(k) clearance for the DISPOSABLE MONITORING ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Shanghai Intco Electrode Manufacturing Co., Ltd. (Sandpoint, US). The FDA issued a Cleared decision on September 15, 2004 after a review of 57 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 Shanghai Intco Electrode Manufacturing Co., Ltd. devices

FDA 510(k) Submission Details - K041954

510(k) Number K041954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2004
Decision Date September 15, 2004
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 154
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K041954.
MACTRODE 3
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