Cleared Traditional

K181864 - Polaris RF Ablation System

K181864 is the FDA 510(k) clearance for Polaris RF Ablation System by Baylis Medical Company, Inc.. It is a Class 2 Neurology device (product code GXD) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K181864 · Baylis Medical Company, Inc. · Neurology device
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Jan 2019
Decision
174d
Days
Class 2
Risk

K181864 is an FDA 510(k) clearance for the Polaris RF Ablation System. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on January 2, 2019 after a review of 174 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - 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 Baylis Medical Company, Inc. devices

Submission Details

510(k) Number K181864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2018
Decision Date January 02, 2019
Days to Decision 174 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
26d slower than avg
Panel avg: 148d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 - GXD Generator, Lesion, Radiofrequency

All 14
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K181864.
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K170242 · Stryker Corporation · May 2017
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RFG-3C PLUS
K982489 · Radionics, Inc. · Oct 1998