# K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jul 12, 2006 after 34 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942299 (1995). 46 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050459: Atricure Isolator Transpolar Pen, AtriCure, Inc. (2005) Summary page 1.
- K040812: Detect Surgical Pacing and Mapping Tool, Medtronic Vascular (2004) Summary page 1.
- K971265: Viking Diagnostic Electrode Catheter, C.R. Bard, Inc. (1997) Summary page 1.
- K051749: Cobra Surgical System, Estech, Inc. (2005) Summary page 1.

## Most influential descendants
- K100501: Multifunctional Linear Pen (2010), 9 descendants of its own
- K113475: Estech Cobra Adhere XL 2 Surgical System (2012), 4 descendants of its own
- K130521: Isolator Linear Pen (2013), 3 descendants of its own
- K163408: Isolator Multifunctional Linear Pen (2017), 2 descendants of its own
- K120857: Epi-Sense Guided Coagulation Device with Visitrax (2012), 2 descendants of its own

## Recalls of this device
- Jan 14, 2013 · Class II · Z-0912-2013: Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.

## Indications for use
The IsolatorTM TranspolarTM Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or 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/K061593
Methodology: https://510kreport.com/methodology