510(k) · Cleared
ClearedMicrothermx Microwave Ablation System, Models MTX-180 or MTX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bsd Medical Corp. · NEY System, Ablation, Microwave And Accessories
Cleared on Aug 13, 2010 as substantially equivalent to K081042 (Bsd Medical Systems Corp., 2008) and 2 other predicates after a 147-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it.
- Decided
- Aug 13, 2010
- Review
- 147 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K861904 (1986). 21 ancestors in all, the oldest K790187 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 6 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 5 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 4 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK040279 Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004
- 1 generation backK081042 Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008
- This deviceK100786 Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010
- Descendant · cites it directly · 0 of its ownK141785 Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015
Most influential descendants
Showing 1 of 1 · See all- K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −6 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −5 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −4 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K040279 | Vivaring Microwave Ablation Probe | Vivant Medical, Inc. | 2004 | — |
| −1 | K081042 | Microthermx-100 Microwave Ablation System and Accessories | Bsd Medical Systems Corp. | 2008 | — |
| 0 (this device) | K100786 | Microthermx Microwave Ablation System, Models MTX-180 or MTX | Bsd Medical Corp. | 2010 | — |
| +1 | K141785 | Micro Thermx Microwave Ablation System and Accessories | Bsd Medical Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 3 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K081042 | Microthermx-100 Microwave Ablation System and AccessoriesSummary page 1…Electrosurgical cutting and coagulation device and accessories Product Code- NEY PREDICATE DEVICES MicroThermXlAOO Microwave Ablation System (MTX-1 00) (K081042) Valleylab VivaWave Microwave Ablation System (K053535) Vivant Medical VivaTip Microwave Ablation Probe and Accessories (… | 2008 |
| * | K053535 | Vivawave Microwave Ablation SystemSummary page 1…ssories Product Code- NEY PREDICATE DEVICES MicroThermXlAOO Microwave Ablation System (MTX-1 00) (K081042) Valleylab VivaWave Microwave Ablation System (K053535) Vivant Medical VivaTip Microwave Ablation Probe and Accessories (K032702) Section 5:510(k) Summary… | 2006 |
| * | K032702 | Vivatip Microwave Ablation ProbeSummary page 1…wave Ablation System (MTX-1 00) (K081042) Valleylab VivaWave Microwave Ablation System (K053535) Vivant Medical VivaTip Microwave Ablation Probe and Accessories (K032702) Section 5:510(k) Summary Page 13… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 24 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K141785 (Bsd Medical Corp., 2015) has gone furthest, with 0 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. 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 MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical as well as percutaneous ablation procedures. An optional temperature sensor may be used to monitor tissue temperatures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100786: Microthermx Microwave Ablation System, Models MTX-180 or MTX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100786
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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