Cleared Traditional

K190801 - PressOn Electrode Headset

K190801 is an FDA 510(k) clearance for PressOn Electrode Headset, manufactured by Rhythmlink International, LLC. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K190801 · Rhythmlink International, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
103d
Days
Class 2
Risk

K190801 is an FDA 510(k) clearance for the PressOn Electrode Headset. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on July 10, 2019 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rhythmlink International, LLC devices

FDA 510(k) Submission Details - K190801

510(k) Number K190801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2019
Decision Date July 10, 2019
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 148d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 Neurology devices follow this clearance model.

Regulatory Peers - GXZ Electrode, Needle

All 16
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K190801.
Phantom XL Insulated Dilators
K231691 · TeDan Surgical Innovations, Inc. · Jun 2023
Guardian Needle Electrode
K200984 · Rhythmlink International, LLC · May 2020
Spes Medica Subdermal Needle Electrodes
K192603 · Spes Medica Srl · Nov 2019
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · Stryker Spine · Jul 2011
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007