# K163408: Isolator Multifunctional Linear Pen

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Jan 3, 2017 after 29 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: 10 generations back to K942299 (1995). 50 ancestors in all.
2 later devices descend 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)
- K130521: Isolator Linear Pen, AtriCure, Inc. (2013) Summary page 4.

## Most influential descendants
- K192125: Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (2019), 1 descendant of its own
- 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 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/K163408
Methodology: https://510kreport.com/methodology