# K060054: Oncobionic System

- Pathway: 510(k) (Traditional)
- Applicant: Oncobionics, Inc.
- Decided: Nov 21, 2006 after 319 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- 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: 7 generations back to K942299 (1995). 41 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041340: Guidant Microwave Ablation System, Guidant Corporation, Cardiac Surgery (2004) Summary page 1.
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System, Medtronic Vascular (2003) Summary page 1.

## Most influential descendants
- K080202: Oncobionic System with 6 Probe Output (2008), 11 descendants of its own
- K080376: Oncobionic System (2008), 11 descendants of its own
- K102329: Nanoknife System (2011), 10 descendants of its own
- K150089: NanoKnife System (2015), 8 descendants of its own
- K183385: NanoKnife System (2019), 7 descendants of its own

## Indications for use
The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.

Source page: https://510kreport.com/device/K060054
Methodology: https://510kreport.com/methodology