Cleared Abbreviated

K003804 - SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

K003804 is an FDA 510(k) clearance for SENSI-PREMA NEONATAL ECG ELECTRODES, manufactured by Niko Medical Products. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Abbreviated 510(k) pathway after a 265-day FDA review.

K003804 · Niko Medical Products · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K003804

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Standards-based clearance path.

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 324
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K003804.
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · Medicotest A/S · Jun 2002
NEOLEAD
K011564 · Neotech Products, Inc. · Jan 2002
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000
V QUICK PATCH
K993934 · Vq Corp. · Aug 2000
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
K000690 · Minnesota Mining and Mfg. Co. · May 2000
K003804 · SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
Download PDF FDA Summary Niko Medical Products