# K122611: Coolrail Linear Pen Model Mcri

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Sep 26, 2012 after 30 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). 41 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073605: Atricure Coolrail Linear Pen, AtriCure, Inc. (2008) Summary page 1.

## Most influential descendants
- K183065: Coolrail Linear Pen (2018), 2 descendants of its own
- K190587: Coolrail 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 Coolrail™ linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K122611
Methodology: https://510kreport.com/methodology