# K221358: Isolator® Linear Pen (MLP1); 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)

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Dec 30, 2022 after 233 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K942299 (1995). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192125: Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen, AtriCure, Inc. (2019) Summary page 9.
- K190587: Coolrail Linear Pen, AtriCure, Inc. (2019) Summary page 9.
- K211311: AtriCure Isolator® Synergy™ Surgical Ablation System, AtriCure, Inc. (2021) Summary page 9.
- K210477: AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE, AtriCure, Inc. (2021) Summary page 9.
- K110117: Atricure Bipolar System, AtriCure, Inc. (2011) Summary page 9.

## Indications for use
The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG in Ablation mode. The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The Isolator Transpolar Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery. The AtriCure Isolator Synergy EnCompass Clamp and Guide system is intended to ablate cardiac tissue during surgery. The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

Source page: https://510kreport.com/device/K221358
Methodology: https://510kreport.com/methodology