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 16, 2023 as substantially equivalent to K220472 (Neuwave Medical, Inc., 2022) and 2 other predicates after a 155-day review. Its family tree reaches back 15 generations to 1987.
- Decided
- Nov 16, 2023
- Review
- 155 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K870028 (1987). 47 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 15 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 11 generations between
- 3 generations backK173756 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018
- 2 generations backK200081 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020
- 1 generation backK220472 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2022
- This deviceK231738 NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2023
Show all 15 generations
- Root · 15 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 14 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 13 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 12 generations backK021329 Rita SystemRita Medical Systems · 2002
- 11 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 10 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 9 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 8 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 7 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 6 generations backK122217 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 5 generations backK130399 Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc. · 2013
- 4 generations backK160936 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2016
- 3 generations backK173756 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018
- 2 generations backK200081 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020
- 1 generation backK220472 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2022
- This deviceK231738 NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −14 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −13 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −12 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −11 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −10 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −9 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −8 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −7 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −6 | K122217 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −5 | K130399 | Certus 140 Certusurggt Surgical Tool | Neuwave Medical, Inc. | 2013 | — |
| −4 | K160936 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2016 | — |
| −3 | K173756 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2018 | — |
| −2 | K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2020 | — |
| −1 | K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2022 | — |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K220472 | NEUWAVE Microwave Ablation System and AccessoriesSummary page 5…Accessories is substantially equivalent to the following currently marketed device: Predicate Device - NEUWAVE Microwave Ablation System and Accessories [K220472 with predicate probe PRS15 (originally cleared as part of K200081) & NWSR25 (originally cleared as part of K130399)… | 2022 |
| * | K200081 | NEUWAVE Microwave Ablation System and AccessoriesSummary page 5…y marketed device: Predicate Device - NEUWAVE Microwave Ablation System and Accessories [K220472 with predicate probe PRS15 (originally cleared as part of K200081) & NWSR25 (originally cleared as part of K130399)] NEUWAVE Microwave Ablation System 510(k) Summary Page 1 of 7 === Page… | 2020 |
| * | K130399 | Certus 140 Certusurggt Surgical ToolSummary page 5…crowave Ablation System and Accessories [K220472 with predicate probe PRS15 (originally cleared as part of K200081) & NWSR25 (originally cleared as part of K130399)] NEUWAVE Microwave Ablation System 510(k) Summary Page 1 of 7 Indications for Use The NEUWAVE™ Mic… | 2013 |
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 36 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 47 ancestors have a recall of any class.
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. 2023, 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 as stated in the FDA summary.
https://510kreport.com/device/K231738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231738: 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/K231738
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