Cleared Abbreviated

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 (K003804) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K003804 · Niko Medical Products · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
265d
Days
Class 2
Risk

K003804 is an FDA 510(k) clearance for the SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,4405.... Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Niko Medical Products (Fort Worth, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 265 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Niko Medical Products devices

Submission Details

510(k) Number K003804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2000
Decision Date August 30, 2001
Days to Decision 265 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 23
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K003804.
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989