Cleared Traditional

K221358 - Isolator® Linear Pen (MLP1) (FDA 510(k) Clearance)

Also includes:
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)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221358 · AtriCure, Inc. · Cardiovascular device
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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

Submission Details

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.

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 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