Cleared Traditional

K053011 - PRO-NEO NEONATAL ECG ELECTRODE

K053011 is the FDA 510(k) clearance for PRO-NEO NEONATAL ECG ELECTRODE by Bio Protech, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K053011 · Bio Protech, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
49d
Days
Class 2
Risk

K053011 is an FDA 510(k) clearance for the PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20. 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 December 14, 2005 after a review of 49 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

Submission Details

510(k) Number K053011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date December 14, 2005
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 81
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K053011.
AMBU WHITE SENSOR CFM, CFL
K052944 · Ambu A/S · Oct 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · Ambu A/S · Oct 2006
MACTRODE 3
K060661 · Ge Medical Systems Information Technologies · Apr 2006
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997