# K100501: Multifunctional Linear Pen

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jun 18, 2010 after 116 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: 8 generations back to K942299 (1995). 48 ancestors in all.
9 later devices descend from it; 2 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)
- K050459: Atricure Isolator Transpolar Pen, AtriCure, Inc. (2005) Summary page 1.
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1, AtriCure, Inc. (2006) Summary page 1.
- K073605: Atricure Coolrail Linear Pen, AtriCure, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K192125: Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (2019), 1 descendant of its own

## Indications for use
The Multifunctional 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 AtriCure Ablation and Sensing unit (ASU) or to the ASU Source Switch in Ablation mode. The Multifunctional Linear Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythniias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Source page: https://510kreport.com/device/K100501
Methodology: https://510kreport.com/methodology