Cleared Traditional

K221358 - Isolator® Linear Pen (MLP1)

Also marketed or referenced as:
Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1) Isolator® Synergy Surgical Ablation System (EMR2, EML2) Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System Isolator® Synergy Access Clamp (EMT1)

K221358 is an FDA 510(k) clearance for Isolator Linear Pen (MLP1), manufactured by AtriCure, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K221358 · AtriCure, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
233d
Days
Class 2
Risk

K221358 is an FDA 510(k) clearance for the Isolator® Linear Pen (MLP1). 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 December 30, 2022 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all AtriCure, Inc. devices

FDA 510(k) Submission Details - K221358

510(k) Number K221358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2022
Decision Date December 30, 2022
Days to Decision 233 days
Submission Type Traditional
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
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 43
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K221358.
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
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
Cardioblate Gemini-s Surgical Ablation Device
K200514 · Medtronic · Jun 2020