# K050459: Atricure Isolator Transpolar Pen

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jun 13, 2005 after 110 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: 6 generations back to K942299 (1995). 39 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002) Summary page 1.
- K032132: Tissuelink Floating Ball Model 23-201-1, Tissuelink Medical, Inc. (2003) Summary page 1.
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1, AtriCure, Inc. (2002) Summary page 1.

## Most influential descendants
- K073605: Atricure Coolrail Linear Pen (2008), 13 descendants of its own
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 (2006), 13 descendants of its own
- 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

## 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 Isolator Tm Transpolar Tm pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K050459
Methodology: https://510kreport.com/methodology