510(k) · Cleared
ClearedNEUWAVE Microwave Ablation System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuwave Medical, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Nov 13, 2020 as substantially equivalent to K173756 (Neuwave Medical, Inc., 2018) after a 303-day review. Its family tree reaches back 13 generations to 1987. 2 later devices descend from it.
- Decided
- Nov 13, 2020
- Review
- 303 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K870028 (1987). 45 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 9 generations between
- 3 generations backK130399 Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc. · 2013
- 2 generations backK160936 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2016
- 1 generation backK173756 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018
- This deviceK200081 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK220472 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK231738 NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 12 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 11 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 10 generations backK021329 Rita SystemRita Medical Systems · 2002
- 9 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 8 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 7 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 6 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 5 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 4 generations backK122217 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 3 generations backK130399 Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc. · 2013
- 2 generations backK160936 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2016
- 1 generation backK173756 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018
- This deviceK200081 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −12 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −11 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −10 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −9 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −8 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −7 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −6 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −5 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −4 | K122217 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −3 | K130399 | Certus 140 Certusurggt Surgical Tool | Neuwave Medical, Inc. | 2013 | — |
| −2 | K160936 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2016 | — |
| −1 | K173756 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2018 | — |
| 0 (this device) | K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2020 | — |
| +1 | K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2022 | — |
| +1 | K231738 | NEUWAVE™ Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 NEY? 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 NEY device
- #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 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 |
|---|---|---|---|
| * | K173756 | Certus 140 2.45GHz Ablation SystemSummary page 5…the following currently marketed device: • Predicate Device - Certus 140 2.45 GHz Ablation System and Accessories cleared under K173756 on October 24, 2018. • Reference Device – CertuSurgGT Surgical Tool cleared under K130399 on July 18th,… | 2018 |
| † | K130399 | Certus 140 Certusurggt Surgical Tool | 2013 |
What descends from it? (2)
2 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 33 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 45 ancestors have a recall of any class.
- Of its descendants, K220472 (Neuwave Medical, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NEY devicesNEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NEY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEY
94in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEY
112in 2025
MAUDE reports naming product code NEY, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 145 | 0 | 15 |
| 2009 | 4 | 169 | 0 | 7 |
| 2010 | 3 | 219 | 0 | 28 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 3 | 81 | 0 | 9 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 92 |
| 2016 | 3 | 30 | 0 | 176 |
| 2017 | 3 | 121 | 12 | 225 |
| 2018 | 3 | 90 | 3 | 102 |
| 2019 | 2 | — | 0 | 123 |
| 2020 | 7 | 178 | 0 | 128 |
| 2021 | 4 | 379 | 1 | 217 |
| 2022 | 1 | — | 1 | 142 |
| 2023 | 9 | 155 | 0 | 106 |
| 2024 | 7 | 94 | 0 | 141 |
| 2025 | 1 | — | 0 | 112 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.
The NEUWAVE Microwave Ablation System is not indicated for use in cardiac procedures.
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/K200081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200081: NEUWAVE Microwave Ablation System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200081
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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