Cleared Special

K192125 - Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

K192125 is an FDA 510(k) clearance for Isolator Transpolar Pen, manufactured by AtriCure, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 90-day FDA review.

K192125 · AtriCure, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K192125

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

OCL Device Classification - Class 2, Special Controls

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.
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · AtriCure, Inc. · May 2021
Cardioblate Gemini-s Surgical Ablation Device
K200514 · Medtronic · Jun 2020
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · AtriCure, Inc. · Dec 2019
Cardioblate CryoFlex Surgical Ablation System
K191526 · Medtronic, Inc. · Oct 2019
Coolrail Linear Pen
K190587 · AtriCure, Inc. · Jul 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
K190623 · Medtronic · May 2019
K192125 · Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
Download PDF FDA Summary AtriCure, Inc.