Cleared Special

K190587 - Coolrail Linear Pen

K190587 is an FDA 510(k) clearance for Coolrail Linear 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 139-day FDA review.

K190587 · AtriCure, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
139d
Days
Class 2
Risk

K190587 is an FDA 510(k) clearance for the Coolrail 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 July 24, 2019 after a review of 139 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 - K190587

510(k) Number K190587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2019
Decision Date July 24, 2019
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 K190587.
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · AtriCure, Inc. · Dec 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125 · AtriCure, Inc. · Nov 2019
Cardioblate CryoFlex Surgical Ablation System
K191526 · Medtronic, Inc. · Oct 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
K190623 · Medtronic · May 2019
COBRA Fusion Ablation System
K190151 · AtriCure, Inc. · Feb 2019
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
K182610 · Medtronic · Dec 2018
K190587 · Coolrail Linear Pen
Download PDF FDA Summary AtriCure, Inc.