510(k) Report

510(k) · Cleared

Cleared

Microsulis Tissue Ablation System

K052919510(k) TraditionalCleared Jan 13, 200688-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

Microsulis Americas, Inc. · NEY System, Ablation, Microwave And Accessories

Cleared on Jan 13, 2006 as substantially equivalent to K984552 (Radionics, Inc., 1999) and 3 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1986. 15 later devices descend from it.

Decided
Jan 13, 2006
Review
88 days
Class
Class II
Product code
NEY
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K861904 (1986). 16 ancestors in all, the oldest K790187 (1979). 15 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1996: 3 other ancestors1986: 1 other ancestor1984: 2 other ancestors1983: 1 other ancestor1979: 1 other ancestor2008: 1 descendant cleared2007: 1 descendant cleared2015: 3 descendants cleared2009: 2 descendants cleared2018: 2 descendants cleared2011: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant clearedK861904 · HS-15M Microwave Surgery Equipment, Microtaze · Cooper Lasersonics, Inc. · 1986K011676 · Vivawave Microwave System · Vivant Medical, Inc. · 2002 · recalled×3: 3 generations cleared close together, K023311 (2003), K032047 (2003), K032702 (2003) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K032702 · 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+5
  1. Root · 5 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
  2. 4 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
  3. 3 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  4. 2 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  5. 1 generation backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
  6. This deviceK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
  7. Descendant · cites it directly · 11 of its ownK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
  8. Descendant · 2 generations on · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
  9. Descendant · 3 generations on · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
  10. Descendant · 2 generations on · 3 of its ownK181941 Swift SystemEmblation, Ltd. · 2018
  11. Descendant · 4 generations on · 3 of its ownK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 22011: 12013: 12015: 32016: 12018: 22023: 12024: 12025: 1
2007high 3 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 15 · See all
  • K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008 · cites it directly11descendants
  • K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · 2 generations on10descendants
  • K103014Miradry SystemMiramar Labs, Inc. · 2011 · 3 generations on5descendants
  • K181941Swift SystemEmblation, Ltd. · 2018 · 2 generations on3descendants
  • K131162Miradry SystemMiramar Labs, Inc. · 2013 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K861904HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc.1986—
−4K011676Vivawave Microwave SystemVivant Medical, Inc.20021
−3K023311Loop Microwave Ablation ProbeVivant Medical, Inc.2003—
−2K032047Tri-Loop Microwave Ablation ProbeVivant Medical, Inc.2003—
−1K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc.2003—
0 (this device)K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc.2006—
+1K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.2008—
+2K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc.2009—
+3K103014Miradry SystemMiramar Labs, Inc.20112
+2K181941Swift SystemEmblation, Ltd.2018—
+4K131162Miradry SystemMiramar Labs, Inc.20131

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198310
198420
198610
199630
199810
199910
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200920
201110
201310
201530
201610
201820
202310
202410
202510
FIG. 1 — Lineage of K052919, 1986–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K984552Cool-Tip RF System
Summary page 1
…(MTA) System and accessories are for use in the intraoperative coagulation tissue. Predicate Devices * Tyco/Radionics Cool-Tip TM RF System K984552 * Vivant Medical VivaWaveTM Microwave System K011676 * Vivant VivaThermTM Temperature Measuremen…
Radionics, Inc.19991
*K011676Vivawave Microwave System
Summary page 1
…issue. Predicate Devices * Tyco/Radionics Cool-Tip TM RF System K984552 * Vivant Medical VivaWaveTM Microwave System K011676 * Vivant VivaThermTM Temperature Measurement System K031556 * Vivant VivaTip Microwave Ablation Probe a…
Vivant Medical, Inc.20021
*K031556Vivatherm Themperature Measurement System
Summary page 1
…K984552 * Vivant Medical VivaWaveTM Microwave System K011676 * Vivant VivaThermTM Temperature Measurement System K031556 * Vivant VivaTip Microwave Ablation Probe and Accessories K032702 Device Description…
Vivant Medical, Inc.2003—
*K032702Vivatip Microwave Ablation Probe
Summary page 1
…stem K011676 * Vivant VivaThermTM Temperature Measurement System K031556 * Vivant VivaTip Microwave Ablation Probe and Accessories K032702 Device Description…
Vivant Medical, Inc.2003—

Also cleared against K984552: 11 other devices →

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811
K070356Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20072

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 10 months on median.
  • 2 of the 16 ancestors have a recall of any class.
  • Of its descendants, K072870 (Foundry Newco X, Inc., 2008) has gone furthest, with 11 descendants of its own.
  • 11 other devices also cite its predicate K984552.

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.

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 Microsulis Tissue Ablation (MTA) System is indicated for the intraoperative coagulation of soft tissue.

Indications for use as stated in the FDA summary.

Also cleared against K984552

11 other devices cite the same predicate.

  • K120116Serf Ablation System Serf Ablation NeedleThermedical · 2012
  • K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
  • K072261Finesse SystemPrimaeva Medical, Inc. · 2007
  • K070356Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated · 2007
  • K070446Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP · 2007
  • K070101Uniblate Electrosurgical DeviceRita Medical Systems, Inc. · 2007

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/K052919 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052919: Microsulis Tissue Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052919

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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