Cleared Special

K192125 - Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (FDA 510(k) Clearance)

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

K192125 · AtriCure, Inc. · Cardiovascular device
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Nov 2019
Decision
90d
Days
Class 2
Risk

K192125 is an FDA 510(k) clearance for the Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on November 4, 2019 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K192125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2019
Decision Date November 04, 2019
Days to Decision 90 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
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 - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K192125.
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · AtriCure, Inc. · Jul 2025
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · AtriCure, Inc. · Aug 2024
Isolator® Linear Pen (MLP1)
K221358 · AtriCure, Inc. · Dec 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · Medtronic, Inc. · Dec 2022
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · AtriCure, Inc. · Jul 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · AtriCure, Inc. · May 2021