# K192125: Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Nov 4, 2019 after 90 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: 11 generations back to K942299 (1995). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163408: Isolator Multifunctional Linear Pen, AtriCure, Inc. (2017) Summary page 5.
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1, AtriCure, Inc. (2006) Summary page 5.

## Most influential descendants
- 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) (2022), 0 descendants of its own

## Indications for use
The Isolator Transpolar Pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch in Ablation mode. When the Pen is connected to the ASU Source Switch in Auxiliary mode, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias. The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB 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.

Source page: https://510kreport.com/device/K192125
Methodology: https://510kreport.com/methodology