510(k) · Cleared
ClearedOncobionic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oncobionics, Inc. · OAB Low Energy Direct Current Thermal Ablation System
Cleared on Nov 21, 2006 as substantially equivalent to K041340 (Guidant Corporation, Cardiac Surgery, 2004) and 1 other predicate after a 319-day review. Its family tree reaches back 7 generations to 1995. 14 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 319 days
- Class
- Class II
- Product code
- OAB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K942299 (1995). 41 ancestors in all, the oldest K811390 (1981). 14 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 5 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 4 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 3 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 2 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 1 generation backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- This deviceK060054 Oncobionic SystemOncobionics, Inc. · 2006
- Descendant · cites it directly · 11 of its ownK080202 Oncobionic System with 6 Probe OutputOncobionics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 11 of its ownK080376 Oncobionic SystemOncobionic Incorporated · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 8 of its ownK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 7 of its ownK183385 NanoKnife SystemAngiodynamics · 2019 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K080202Oncobionic System with 6 Probe OutputOncobionics, Inc. · 2008 · cites it directly11descendants
- K080376Oncobionic SystemOncobionic Incorporated · 2008 · cites it directly11descendants
- K102329Nanoknife SystemAngioDynamics, Inc. · 2011 · 2 generations on10descendants
- K150089NanoKnife SystemAngioDynamics, Inc. · 2015 · 3 generations on8descendants
- K183385NanoKnife SystemAngiodynamics · 2019 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −6 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −5 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −4 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −3 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −1 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| 0 (this device) | K060054 | Oncobionic System | Oncobionics, Inc. | 2006 | — |
| +1 | K080202 | Oncobionic System with 6 Probe Output | Oncobionics, Inc. | 2008 | 1 |
| +1 | K080376 | Oncobionic System | Oncobionic Incorporated | 2008 | 1 |
| +2 | K102329 | Nanoknife System | AngioDynamics, Inc. | 2011 | 1 |
| +3 | K150089 | NanoKnife System | AngioDynamics, Inc. | 2015 | 1 |
| +4 | K183385 | NanoKnife System | Angiodynamics | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OAB device
- #1 K253826 Aliya® EX System; Aliya® EX Generator; Aliya®…score 15.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041340 | Guidant Microwave Ablation SystemSummary page 1…Number: (949) 888-6659 Contact Person: Paul Mikus, Regulatory Manager Predicate Device: The Guidant Microwave Ablation System (K041340) and Medtronic Cardioblate Bipolar Radiofrequency Ablation (K031247). Date Prepared: Oc… | 2004 |
| * | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation SystemSummary page 1…er Predicate Device: The Guidant Microwave Ablation System (K041340) and Medtronic Cardioblate Bipolar Radiofrequency Ablation (K031247). Date Prepared: October 30, 2006 Indications For Use: The Oncobionic System… | 2003 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K080202 (Oncobionics, Inc., 2008) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K041340.
How does its category compare?
All OAB devicesOAB Low Energy Direct Current Thermal Ablation System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OAB
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OAB
129in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAB
10in 2025
MAUDE reports naming product code OAB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 16 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 4 | 129 | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060054: Oncobionic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060054
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026