# K022008: Cardima Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Cardima, Inc.
- Decided: Jan 29, 2003 after 224 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921884 (1992). 7 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981981: Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19, Boston Scientific Corp (1998) Summary page 1.
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K021722: AtriCure Bipolar Coagulator. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K022894: Epicor Medical Ablation System (2004), 23 descendants of its own
- K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1 (2004), 22 descendants of its own
- K043579: Atricure Bipolar System (2007), 18 descendants of its own
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device (2008), 10 descendants of its own
- K101174: Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2 (2010), 6 descendants of its own

## Recalls of this device
- May 20, 2010 · Not classified · Z-2580-2010: Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
- May 20, 2010 · Not classified · Z-2581-2010: Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.

## Indications for use
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy

Source page: https://510kreport.com/device/K022008
Methodology: https://510kreport.com/methodology