510(k) · Cleared
Recalled · 2009Vivawave Microwave System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivant Medical, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Jun 18, 2002 as substantially equivalent to K864413 (Cooper Lasersonics, Inc., 1986) and 4 other predicates after a 384-day review. Its family tree reaches back 1 generation to 1986. 67 later devices descend from it. It has been recalled once.
- Decided
- Jun 18, 2002
- Review
- 384 days
- Class
- Class II
- Product code
- NEY
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K861904 (1986). 5 ancestors in all. 67 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- This deviceK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002
- Descendant · cites it directly · 50 of its ownK053535 Vivawave Microwave Ablation SystemValleylab · 2006
- Descendant · cites it directly · 41 of its ownK070023 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007
- Descendant · 2 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- Descendant · 3 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- Descendant · 4 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K053535Vivawave Microwave Ablation SystemValleylab · 2006 · cites it directly50descendants
- K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007 · cites it directly41descendants
- K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · 2 generations on39descendants
- K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 3 generations on38descendants
- K133821Emprint Ablation SystemCovidien, LLC · 2014 · 4 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| 0 (this device) | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | — |
| +1 | K053535 | Vivawave Microwave Ablation System | Valleylab | 2006 | — |
| +1 | K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 | Microsurgeon, Inc. | 2007 | — |
| +2 | 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 | — |
| +4 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
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 |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K864413 | Model Hse-5M Microwave Surgery Equipment/MicrotazeSummary page 4…d Use The VivaWaveTMMicrowave System is intended for coagulation of soft tissue Predicate Devices HSE-5M Microtaze - Cooper Lasersonics, Inc. K864413 HHS- 15M Microtaze - Cooper Lasersonics, Inc. K861904 RF-2000 RF Generator - RadioTherapeutics Corp K98… | 1986 |
| * | K861904 | HS-15M Microwave Surgery Equipment, MicrotazeSummary page 4…ion of soft tissue Predicate Devices HSE-5M Microtaze - Cooper Lasersonics, Inc. K864413 HHS- 15M Microtaze - Cooper Lasersonics, Inc. K861904 RF-2000 RF Generator - RadioTherapeutics Corp K981672 LeVeen Needle Electrode - RadioTherapeutics Corp K96… | 1986 |
| * | K981672 | Radiotherapeutics RF-2000 Radiofrequency GeneratorSummary page 4…Cooper Lasersonics, Inc. K864413 HHS- 15M Microtaze - Cooper Lasersonics, Inc. K861904 RF-2000 RF Generator - RadioTherapeutics Corp K981672 LeVeen Needle Electrode - RadioTherapeutics Corp K962313 Model 30-6 Multielectrode Array Probe - Zomed Intl K96… | 1998 |
| * | K962313 | Modified Leveen Needle ElectrodeSummary page 4…- Cooper Lasersonics, Inc. K861904 RF-2000 RF Generator - RadioTherapeutics Corp K981672 LeVeen Needle Electrode - RadioTherapeutics Corp K962313 Model 30-6 Multielectrode Array Probe - Zomed Intl K962692 Device Description The VivaWaveTM Microwave System cons… | 1996 |
| * | K962692 | Zomed Model 30-6 Multielectrode Array ProbeSummary page 4…or - RadioTherapeutics Corp K981672 LeVeen Needle Electrode - RadioTherapeutics Corp K962313 Model 30-6 Multielectrode Array Probe - Zomed Intl K962692 Device Description The VivaWaveTM Microwave System consists of a n external microwave generator and probe. The genera… | 1996 |
What descends from it? (67)
See all 679 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053535 | Vivawave Microwave Ablation System | 2006 | 50 |
| K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 | 2007 | 41 |
| K023311 | Loop Microwave Ablation Probe | 2003 | 28 |
| K032702 | Vivatip Microwave Ablation Probe | 2003 | 26 |
| K052919 | Microsulis Tissue Ablation System | 2006 | 15 |
| K072870 | Microwave Tissue Coagulation System (MTCS) | 2008 | 11 |
| K081042 | Microthermx-100 Microwave Ablation System and Accessories | 2008 | 2 |
| K070356 | Medwaves Microwave Coagulation/Ablation System | 2007 | 2 |
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2009 | Not classified | Z-3092-2011 | Component design/selection | Generator may deliver full power when a lower power is selected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
- Of its descendants, K053535 (Valleylab, 2006) has gone furthest, with 50 descendants 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.
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 VivaWave™ Microwave System is intended for coagulation of soft tissue
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/K011676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011676: Vivawave Microwave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011676
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026