510(k) · Cleared
ClearedCertus 140 2.45GHz Ablation System
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 May 4, 2016 as substantially equivalent to K100744 (Neuwave Medical, Inc., 2010) and 3 other predicates after a 30-day review. Its family tree reaches back 11 generations to 1987. 5 later devices descend from it.
- Decided
- May 4, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K870028 (1987). 43 ancestors in all, the oldest K811390 (1981). 5 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 7 generations between
- 3 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 2 generations backK122217 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK130399 Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc. · 2013
- This deviceK160936 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK173756 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK200081 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK220472 NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK231738 NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK163118 FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 10 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 9 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 8 generations backK021329 Rita SystemRita Medical Systems · 2002
- 7 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 6 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 5 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 4 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 3 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 2 generations backK122217 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK130399 Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc. · 2013
- This deviceK160936 Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018 · cites it directly3descendants
- K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020 · 2 generations on2descendants
- K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2022 · 3 generations on1descendant
- K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2023 · 3 generations on0descendants
- K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −10 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −9 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −8 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −7 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −6 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −5 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −4 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −3 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −2 | K122217 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −1 | K130399 | Certus 140 Certusurggt Surgical Tool | Neuwave Medical, Inc. | 2013 | — |
| 0 (this device) | K160936 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2016 | — |
| +1 | K173756 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2018 | — |
| +2 | K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2020 | — |
| +3 | K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2022 | — |
| +3 | K231738 | NEUWAVE™ Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2023 | — |
| +1 | K163118 | FLEX Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140Summary page 4…• Certus 140 2.45 GHz Ablation System and Accessories – Class II – 21CFG878.4400 which has been the subject of a cleared 510(k) with the FDA log number K100744, K113237, K122217 and K130399. Indications For Use The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and A… | 2010 |
| * | K113237 | Certus 140 2.45GHZ Ablation SystemSummary page 4…us 140 2.45 GHz Ablation System and Accessories – Class II – 21CFG878.4400 which has been the subject of a cleared 510(k) with the FDA log number K100744, K113237, K122217 and K130399. Indications For Use The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessorie… | 2012 |
| * | K122217 | Certus 140 2.45GHZ Ablation SystemSummary page 4…System and Accessories – Class II – 21CFG878.4400 which has been the subject of a cleared 510(k) with the FDA log number K100744, K113237, K122217 and K130399. Indications For Use The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the… | 2012 |
| * | K130399 | Certus 140 Certusurggt Surgical ToolSummary page 4…Accessories – Class II – 21CFG878.4400 which has been the subject of a cleared 510(k) with the FDA log number K100744, K113237, K122217 and K130399. Indications For Use The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (co… | 2013 |
What descends from it? (5)
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 29 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 43 ancestors have a recall of any class.
- Of its descendants, K173756 (Neuwave Medical, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K100744.
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. 2016, 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 Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings.
The Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures.
The system is designed for facility use and should only be used under the orders of a clinician.
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/K160936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160936: Certus 140 2.45GHz Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160936
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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