510(k) · Cleared
ClearedIrreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Curaway Medical Technology Co., Ltd. · OAB Low Energy Direct Current Thermal Ablation System
Cleared on Jun 8, 2023 as substantially equivalent to K183385 (Angiodynamics, 2019) after a 336-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Jun 8, 2023
- Review
- 336 days
- Class
- Class II
- Product code
- OAB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K942299 (1995). 50 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations between
- 3 generations backK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
- 2 generations backK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
- 1 generation backK183385 NanoKnife SystemAngiodynamics · 2019 · Recalled
- This deviceK222001 Irreversible Electroporation Ablation Generator, Irreversible…Zhejiang Curaway Medical Technology Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 11 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 10 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 9 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 8 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 7 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 6 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 5 generations backK060054 Oncobionic SystemOncobionics, Inc. · 2006
- 4 generations backK080376 Oncobionic SystemOncobionic Incorporated · 2008 · Recalled
- 3 generations backK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
- 2 generations backK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
- 1 generation backK183385 NanoKnife SystemAngiodynamics · 2019 · Recalled
- This deviceK222001 Irreversible Electroporation Ablation Generator, Irreversible…Zhejiang Curaway Medical Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −11 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −10 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −9 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −8 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −7 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −6 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −5 | K060054 | Oncobionic System | Oncobionics, Inc. | 2006 | — |
| −4 | K080376 | Oncobionic System | Oncobionic Incorporated | 2008 | 1 |
| −3 | K102329 | Nanoknife System | AngioDynamics, Inc. | 2011 | 1 |
| −2 | K150089 | NanoKnife System | AngioDynamics, Inc. | 2015 | 1 |
| −1 | K183385 | NanoKnife System | Angiodynamics | 2019 | 1 |
| 0 (this device) | K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation… | Zhejiang Curaway Medical Technology Co., Ltd. | 2023 | — |
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 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K183385 | NanoKnife SystemSummary page 4…Review panel General & Plastic Surgery (SU) Regulation number 878.4400 Product code OAB Predicate device Nanoknife system (K183385) Reference device The VIVA combo RF System (K163450) Device Description The Irreversible Electroporati… | 2019 |
| † | K163450 | VIVA combo RF System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 9 companies; a new generation was cleared every 3.3 years on median.
- 9 of the 50 ancestors have a recall of any class.
- 3 other devices also cite its predicate K183385.
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. 2023, this device’s year, is highlighted.
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 Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.
The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation Ablation Generator of CuraWay indicated for the surgical ablation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222001 · printed Nov 3, 2026
Cite this page
510(k) Report. “K222001: Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K222001
Report an extraction error
Are you the manufacturer?
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