510(k) Report

510(k) · Cleared

Cleared

Tri-Loop Microwave Ablation Probe

K032047510(k) SpecialCleared Aug 6, 200335-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

Vivant Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 6, 2003 as substantially equivalent to K023311 (Vivant Medical, Inc., 2003) after a 35-day review. Its family tree reaches back 3 generations to 1986. 27 later devices descend from it.

Decided
Aug 6, 2003
Review
35 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K861904 (1986). 8 ancestors in all, the oldest K790187 (1979). 27 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1979: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1986: 1 other ancestor2003: 1 descendant cleared2009: 3 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2008: 2 descendants cleared2016: 2 descendants cleared2010: 1 descendant cleared2015: 5 descendants cleared2007: 1 descendant cleared2023: 2 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2011: 1 descendant cleared2025: 1 descendant cleared2024: 2 descendants cleared2013: 1 descendant clearedK861904 · HS-15M Microwave Surgery Equipment, Microtaze · Cooper Lasersonics, Inc. · 1986K011676 · Vivawave Microwave System · Vivant Medical, Inc. · 2002 · recalledK023311 · Loop Microwave Ablation Probe · Vivant Medical, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant K023311 · 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. · 19860+5
  1. Root · 3 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
  2. 2 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
  3. 1 generation backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  4. This deviceK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
  5. Descendant · cites it directly · 26 of its ownK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
  6. Descendant · 2 generations on · 15 of its ownK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
  7. Descendant · 3 generations on · 11 of its ownK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
  8. Descendant · 4 generations on · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
  9. Descendant · 5 generations on · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12006: 12007: 12008: 22009: 32010: 12011: 12013: 12015: 52016: 22018: 22019: 12023: 22024: 22025: 1
2003high 5 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 27 · See all
  • K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003 · cites it directly26descendants
  • K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006 · 2 generations on15descendants
  • K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008 · 3 generations on11descendants
  • K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · 4 generations on10descendants
  • K103014Miradry SystemMiramar Labs, Inc. · 2011 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
199620
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200610
200710
200820
200930
201010
201110
201310
201550
201620
201820
201910
202320
202420
202510
FIG. 1 — Lineage of K032047, 1986–2025Source: 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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
*K023311Loop Microwave Ablation ProbeVivant Medical, Inc.2003—

Also cleared against K023311: 1 other device →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc.200326

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 17 years and passes through 2 companies; a new generation was cleared every 10 months on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K032702 (Vivant Medical, Inc., 2003) has gone furthest, with 26 descendants of its own.
  • 1 other device also cites its predicate K023311.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Tri-Loop Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

Indications for use as stated in the FDA summary.

Also cleared against K023311

1 other device cites the same predicate.

  • K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004

More from Vivant Medical, Inc.

10 FDA decisions under this applicant name. See the company

  • K050223Vivawave Microwave Ablation System, Coaxial IntroducerVivant Medical, Inc. · 2005
  • K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004
  • K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
  • K031556Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 2003
  • K023311Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003

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https://510kreport.com/device/K032047 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032047: Tri-Loop Microwave Ablation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032047

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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