510(k) · Cleared
ClearedCertus 140 Microwave Ablation System and Accessories, Model Certus 140
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 Oct 22, 2010 as substantially equivalent to K072687 (Covidien Lp, Formerly Know AS Valleylab, A Divison, 2008) and 6 other predicates after a 220-day review. Its family tree reaches back 7 generations to 1987. 39 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 220 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K870028 (1987). 39 ancestors in all, the oldest K811390 (1981). 39 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 5 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 4 generations backK021329 Rita SystemRita Medical Systems · 2002
- 3 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 2 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 1 generation backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- This deviceK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- Descendant · cites it directly · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- Descendant · 2 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- Descendant · 3 generations on · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- Descendant · 3 generations on · 9 of its ownK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- Descendant · cites it directly · 8 of its ownK122217 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · cites it directly38descendants
- K133821Emprint Ablation SystemCovidien, LLC · 2014 · 2 generations on29descendants
- K163105Emprint Ablation SystemCovidien, LLC · 2016 · 3 generations on13descendants
- K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019 · 3 generations on9descendants
- K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −6 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −5 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −4 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −3 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −2 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −1 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| 0 (this device) | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| +1 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| +2 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| +3 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| +3 | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
| +1 | K122217 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K072687 | Valleylab Microwave Ablation GeneratorSummary page 1…* ValleyLab Microwave Ablation Generator - Class II - 21CFRS7S.4400, which has been the subject of a cleared 510(k) with FDA log number 072687 and K053535. * ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories - Class II -… | 2008 |
| * | K053535 | Vivawave Microwave Ablation SystemSummary page 1…* ValleyLab Microwave Ablation Generator - Class II - 21CFRS7S.4400, which has been the subject of a cleared 510(k) with FDA log number 072687 and K053535. * ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories - Class II - 21CFR878.44… | 2006 |
| * | K052796 | Cool-Tip RF Generator, Cool-Tip RF System AccessoriesSummary page 1…, Cool-Tip RF System and Accessories - Class II - 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number K(052796 and K(053290. * EndloCare CryoCare Surgical System, Model Cryo 20 - Class II - 21CFR878.4350, which… | 2006 |
| * | K053290 | Cool-Tip RF Generator, Cool-Tip RF System AccessoriesSummary page 1…System and Accessories - Class II - 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number K(052796 and K(053290. * EndloCare CryoCare Surgical System, Model Cryo 20 - Class II - 21CFR878.4350, which has been… | 2006 |
| * | K023757 | Cryocare Surgical System, Model Cryo 20Summary page 1…* EndloCare CryoCare Surgical System, Model Cryo 20 - Class II - 21CFR878.4350, which has been the subject of a cleared 510(k) with FDA log number K023757. * Microsurgeon Microwave Tissue Ablation Device - Class 11- 21CFR878.4400, which has been the… | 2002 |
| * | K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Summary page 1…* Microsurgeon Microwave Tissue Ablation Device - Class 11- 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number 070023 * Boston Scientific RF 3000Generator - Class 11- 21CFR878.4400, which has been the subject of a… | 2007 |
| * | K000241 | Radiotherapeutics RF 3000 Radiofrequency GeneratorSummary page 1…0023 * Boston Scientific RF 3000Generator - Class 11- 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number K000241 Intended Use The NeuWave Medical Certus 140 2.45 GI-z Ablation System and Accessories are intended for the ablation (coagulation… | 2000 |
What descends from it? (39)
See all 396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113237 | Certus 140 2.45GHZ Ablation System | 2012 | 38 |
| K122217 | Certus 140 2.45GHZ Ablation System | 2012 | 8 |
| K130399 | Certus 140 Certusurggt Surgical Tool | 2013 | 6 |
| K160936 | Certus 140 2.45GHz Ablation System | 2016 | 5 |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation… | 2024 | 0 |
| K163118 | FLEX Microwave Ablation System and Accessories | 2017 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 39 ancestors have a recall of any class.
- Of its descendants, K113237 (Neuwave Medical, Inc., 2012) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K072687.
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. 2010, 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 0Hz Ablation System and Accessories are intended for
the ablation (coagulation) of soft tissue.
The Gertus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures.
NeuWave recommends against the use of the Certus 140 2.45 0Hz Ablation System in the
following situations:
* Pregnant patients - potential risks to patient and/or fetus have not been established
* Patients with implantable pacemakers or other electronic implants. Implanted electronic
devices may be adversely affected by microwave power
The system is designed for facility use and should only be used under the orders of a clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100744 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100744
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