Cleared Traditional

K052019 - NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE

K052019 is an FDA 510(k) clearance for NORTH COAST BUFFERED IONTOPHORESIS ELEC..., manufactured by North Coast Medical, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K052019 · North Coast Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
101d
Days
Class 2
Risk

K052019 is an FDA 510(k) clearance for the NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by North Coast Medical, Inc. (Morgan Hill, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K052019

510(k) Number K052019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date November 04, 2005
Days to Decision 101 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 116d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 69
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K052019.
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814 · Dynatronics Corp. · Jun 2006
COMFORT/IO IONTOPHORESIS ELECTRODES
K060579 · Pepin Mfg., Inc. · Apr 2006
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236 · Iomed, Inc. · Mar 2006
DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · Dynatronics Corp. · Jan 2005
TRANSDERM IONTO SYSTEM, MK 2
K042590 · Mattioli Engineering Corp. · Oct 2004
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
K041101 · Medical Adhesiveonline, LLC · Jul 2004
K052019 · NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
Download PDF FDA Summary North Coast Medical, …