510(k) Report

FDA applicant

Oncobionics, Inc.

Washington, DC2 decisions2006–20081 recall

FDA records 2 decisions for Oncobionics, Inc. (Washington, DC) from 2006 to 2008: 2 510(k) clearances. All are in product code OAB (Low Energy Direct Current Thermal Ablation…). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Oncobionics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Oncobionics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oncobionics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OABLow Energy Direct Current Thermal Ablation System2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060054Oncobionic SystemOncobionics, Inc. · 20063cite it
  • K080202Oncobionic System with 6 Probe OutputOncobionics, Inc. · 20081cites it

What has FDA decided for it lately?

  • K080202Oncobionic System with 6 Probe OutputOncobionics, Inc. · 20081 recall
  • K060054Oncobionic SystemOncobionics, Inc. · 2006

All 2 as Oncobionics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080202NanoKnife Irreversible Electroporation System. System consists of multiple components…Jan 20, 2012