510(k) · Cleared
ClearedVivawave Microwave Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab · NEY System, Ablation, Microwave And Accessories
Cleared on Apr 27, 2006 as substantially equivalent to K011676 (Vivant Medical, Inc., 2002) after a 129-day review. Its family tree reaches back 2 generations to 1986. 50 later devices descend from it.
- Decided
- Apr 27, 2006
- Review
- 129 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861904 (1986). 6 ancestors in all. 50 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 1 generation backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- This deviceK053535 Vivawave Microwave Ablation SystemValleylab · 2006
- Descendant · cites it directly · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- Descendant · 2 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- Descendant · 3 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- Descendant · 4 generations on · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- Descendant · 4 generations on · 9 of its ownK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · cites it directly39descendants
- K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 2 generations on38descendants
- K133821Emprint Ablation SystemCovidien, LLC · 2014 · 3 generations on29descendants
- K163105Emprint Ablation SystemCovidien, LLC · 2016 · 4 generations on13descendants
- K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −1 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| 0 (this device) | K053535 | Vivawave Microwave Ablation System | Valleylab | 2006 | — |
| +1 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| +2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| +3 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| +4 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| +4 | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 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? (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 |
|---|---|---|---|
| * | K011676 | Vivawave Microwave SystemSummary page 1…ave Ablation System is substantially equivalent in function and intended use to the following legally marketed device: Vivant Medical VivaWave TM Microwave System (K011676). The VivaWave T M Microwave Ablation System (this submission) has three (3) or six (6) microwave output channels, each of whi… | 2002 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | 2010 | 39 |
| K083157 | HS Amica | 2009 | 4 |
| K081042 | Microthermx-100 Microwave Ablation System and Accessories | 2008 | 2 |
| K070356 | Medwaves Microwave Coagulation/Ablation System | 2007 | 2 |
| K100786 | Microthermx Microwave Ablation System, Models MTX-180 or MTX | 2010 | 1 |
| K141785 | Micro Thermx Microwave Ablation System and Accessories | 2015 | 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 20 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K100744 (Neuwave Medical, Inc., 2010) has gone furthest, with 39 descendants of its own.
- 8 other devices also cite its predicate K011676.
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.
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 VivaWaveTM Microwave Ablation System is intended for coagulation (ablation) of soft tissue.
The VivaWave TM Microwave Ablation System is not intended for use in cardiac procedures.
Valleylab recommends against the use of microwave ablation in the following situations:
* Pregnant patients - potential risks to the patient and/or fetus have not been established.
* Patients with implantable pacemakers and other electronic implants. Implanted electronic devices may be adversely affected by microwave power output.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053535: Vivawave Microwave Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053535
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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