Cleared Special

K092337 - PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (FDA 510(k) Clearance)

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

K092337 · Baylis Medical Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
73d
Days
Class 2
Risk

K092337 is an FDA 510(k) clearance for the PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on October 16, 2009 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K092337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date October 16, 2009
Days to Decision 73 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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 - GXI Probe, Radiofrequency Lesion

All 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K092337.
Disposable Radiofrequency Cannula
K253907 · Abbott Medical · Apr 2026
STAR RF Ablation System
K251802 · Merit Medical Systems, Inc. · Feb 2026
OneRF Trigeminal Nerve Radiofrequency Probes
K251243 · Neuroone Medical Technologies Corp. · Aug 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · Abbott Medical · May 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · Stryker Instruments · May 2025
RF Cannula
K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Jan 2025