510(k) Report

510(k) · Cleared

Cleared

Microthermx-100 Microwave Ablation System and Accessories

K081042510(k) TraditionalCleared Sep 3, 2008145-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bsd Medical Systems Corp. · NEY System, Ablation, Microwave And Accessories

Cleared on Sep 3, 2008 as substantially equivalent to K833158 (Bsd Medical Corp., 1984) and 7 other predicates after a 145-day review. Its family tree reaches back 6 generations to 1986. 2 later devices descend from it.

Decided
Sep 3, 2008
Review
145 days
Class
Class II
Product code
NEY
Recalls
None
Predicates
8

Its longest line of descent runs back 6 generations to K861904 (1986). 20 ancestors in all, the oldest K790187 (1979). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1995: 1 other ancestor1984: 3 other ancestors1998: 1 other ancestor1996: 3 other ancestors1986: 1 other ancestor1983: 1 other ancestor1979: 1 other ancestor2010: 1 descendant cleared2015: 1 descendant clearedK861904 · HS-15M Microwave Surgery Equipment, Microtaze · Cooper Lasersonics, Inc. · 1986K011676 · Vivawave Microwave System · Vivant Medical, Inc. · 2002 · recalled×4: 4 generations cleared close together, K023311 (2003), K032047 (2003), K032702 (2003), K040279 (2004) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K040279 · Vivaring Microwave Ablation Probe · Vivant Medical, Inc. · 2004K032702 · Vivatip Microwave Ablation Probe · Vivant Medical, Inc. · 2003K032047 · Tri-Loop Microwave Ablation Probe · Vivant Medical, Inc. · 2003K023311 · Loop Microwave Ablation Probe · Vivant Medical, Inc. · 2003K011676 · Vivawave Microwave System · Vivant Medical, Inc. · 2002 · recalledK861904 · HS-15M Microwave Surgery Equipment, Microtaze · Cooper Lasersonics, Inc. · 1986−50
  1. Root · 6 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
  2. 5 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
  3. 4 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  4. 3 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  5. 2 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
  6. 1 generation backK040279 Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004
  7. This deviceK081042 Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008
  8. Descendant · cites it directly · 1 of its ownK100786 Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010
  9. Descendant · 2 generations on · 0 of its ownK141785 Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010 · cites it directly1descendant
  • K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K861904HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc.1986—
−5K011676Vivawave Microwave SystemVivant Medical, Inc.20021
−4K023311Loop Microwave Ablation ProbeVivant Medical, Inc.2003—
−3K032047Tri-Loop Microwave Ablation ProbeVivant Medical, Inc.2003—
−2K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc.2003—
−1K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc.2004—
0 (this device)K081042Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp.2008—
+1K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp.2010—
+2K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198310
198430
198610
199510
199630
199810
200310
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201510
FIG. 1 — Lineage of K081042, 1986–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K833158BSD-200
Summary page 1
…ave Ablation System Classification Name 21 CFR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablatio…
Bsd Medical Corp.1984—
*K950301Angiocath (R) Nonvalon (R) and Angio-Set (R) IV Catheters
Summary page 1
…ion System Classification Name 21 CFR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System…
Becton Dickinson Vascular Access, Inc.1995—
*K011676Vivawave Microwave System
Summary page 1
…m Classification Name 21 CFR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System (MTX-100)…
Vivant Medical, Inc.20021
*K031556Vivatherm Themperature Measurement System
Summary page 1
…lassification Name 21 CFR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers…
Vivant Medical, Inc.2003—
*K032702Vivatip Microwave Ablation Probe
Summary page 1
…tion Name 21 CFR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers mi…
Vivant Medical, Inc.2003—
*K040279Vivaring Microwave Ablation Probe
Summary page 1
…21 CFR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave e…
Vivant Medical, Inc.2004—
*K050223Vivawave Microwave Ablation System, Coaxial Introducer
Summary page 1
…FR§878.4400 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for…
Vivant Medical, Inc.2005—
*K053535Vivawave Microwave Ablation System
Summary page 1
…00 System, Ablation, Microwave and Accessories 4. Predicate Device(s) K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535 5. Device Description The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulat…
Valleylab2006—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp.20101

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 22 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • 1 of the 20 ancestors has a recall of any class.
  • Of its descendants, K100786 (Bsd Medical Corp., 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All NEY devices

NEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NEY

1in 2025

2007: 22008: 32009: 42010: 32012: 32013: 12014: 12015: 22016: 32017: 32018: 32019: 22020: 72021: 42022: 12023: 92024: 72025: 12026 (partial year): 2
2007high 9 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEY

94in 2024

2008: 145 days median2009: 169 days median2010: 219 days median2012: 81 days median2016: 30 days median2017: 121 days median2018: 90 days median2020: 178 days median2021: 379 days median2023: 155 days median2024: 94 days median
2007high 379 (2021) · low 30 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NEY

1in 2022

2017: 122018: 32021: 12022: 1
2007high 12 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NEY

112in 2025

2007: 182008: 152009: 72010: 282011: 262012: 92013: 162014: 272015: 922016: 1762017: 2252018: 1022019: 1232020: 1282021: 2172022: 1422023: 1062024: 1412025: 112
2007high 225 (2017) · low 7 (2009)2025

MAUDE reports naming product code NEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—018
20083145015
2009416907
20103219028
20110—026
201238109
20131—016
20141—027
20152—092
20163300176
2017312112225
20183903102
20192—0123
202071780128
202143791217
20221—1142
202391550106
20247940141
20251—0112
20262—0—

What is it indicated for?

The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures.

The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be used in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.

Indications for use as stated in the FDA summary.

Recent decisions in NEY

The NEY category page

  • K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd. · 2026
  • K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6…Nanjing Devin Medical Technology Co., Ltd. · 2026
  • K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited · 2025
  • K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc. · 2024
  • K241825Microwave Ablation AntennasCanyon Medical, Inc. · 2024

https://510kreport.com/device/K081042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081042: Microthermx-100 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/K081042

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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