510(k) · Cleared
ClearedMicro Thermx Microwave Ablation System and Accessories
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 Mar 31, 2015 as substantially equivalent to K100786 (Bsd Medical Corp., 2010) and 3 other predicates after a 272-day review. Its family tree reaches back 8 generations to 1986.
- Decided
- Mar 31, 2015
- Review
- 272 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K861904 (1986). 40 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 7 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 6 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 5 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 4 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK040279 Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004
- 2 generations backK081042 Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008
- 1 generation backK100786 Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010
- This deviceK141785 Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −7 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −6 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −5 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −4 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K040279 | Vivaring Microwave Ablation Probe | Vivant Medical, Inc. | 2004 | — |
| −2 | K081042 | Microthermx-100 Microwave Ablation System and Accessories | Bsd Medical Systems Corp. | 2008 | — |
| −1 | K100786 | Microthermx Microwave Ablation System, Models MTX-180 or MTX | Bsd Medical Corp. | 2010 | — |
| 0 (this device) | 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 |
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K100786 | Microthermx Microwave Ablation System, Models MTX-180 or MTXSummary page 4…, (21CFR §878.4400), Electrosurgical cutting and coagulation device and accessories Product Code- NEY PREDICATE DEVICES MicroThermX Microwave Ablation System (MTX-180) (K100786). Valleylab (Covidien) Microwave Ablation Generator (K072687). (System also referred to as Vivant Medical VivaWave Microwave Sys… | 2010 |
| * | K072687 | Valleylab Microwave Ablation GeneratorSummary page 4…evice and accessories Product Code- NEY PREDICATE DEVICES MicroThermX Microwave Ablation System (MTX-180) (K100786). Valleylab (Covidien) Microwave Ablation Generator (K072687). (System also referred to as Vivant Medical VivaWave Microwave System - K053535) Valleylab (Covidien) VivaRing Microwave Ablatio… | 2008 |
| * | K053535 | Vivawave Microwave Ablation SystemSummary page 4…Ablation System (MTX-180) (K100786). Valleylab (Covidien) Microwave Ablation Generator (K072687). (System also referred to as Vivant Medical VivaWave Microwave System - K053535) Valleylab (Covidien) VivaRing Microwave Ablation Probe (K040279.) DEVICE DESCRIPTION The MicroThermX® Microwave Ablation System… | 2006 |
| * | K040279 | Vivaring Microwave Ablation ProbeSummary page 4…ave Ablation Generator (K072687). (System also referred to as Vivant Medical VivaWave Microwave System - K053535) Valleylab (Covidien) VivaRing Microwave Ablation Probe (K040279.) DEVICE DESCRIPTION The MicroThermX® Microwave Ablation System (MTX) delivers 915 MHz microwave energy for coagulation (ablatio… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 40 ancestors have a recall of any class.
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. 2015, 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 procedures and in laparoscopic and percutaneous ablation procedures, using image guidance, including partial or complete ablation of non-resectable liver tumors. An optional TempSure temperature sensor may be used to monitor tissue temperatures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141785: Micro Thermx Microwave Ablation System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141785
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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