# K080376: Oncobionic System

- Pathway: 510(k) (Traditional)
- Applicant: Oncobionic Incorporated
- Decided: Apr 2, 2008 after 50 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942299 (1995). 45 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060054: Oncobionic System, Oncobionics, Inc. (2006) Summary page 1.
- K070101: Uniblate Electrosurgical Device, Rita Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode (2022), 2 descendants of its own
- K242687: NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) (2024), 1 descendant of its own

## Recalls of this device
- Apr 4, 2011 · Not classified · Z-3258-2011: Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from

## Indications for use
The Oncobionic System is indicated for surgical ablation of soft tissue

Source page: https://510kreport.com/device/K080376
Methodology: https://510kreport.com/methodology