510(k) · Cleared
ClearedVivaring Microwave Ablation Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivant Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 2, 2004 as substantially equivalent to K023311 (Vivant Medical, Inc., 2003) and 1 other predicate after a 26-day review. Its family tree reaches back 5 generations to 1986. 3 later devices descend from it.
- Decided
- Mar 2, 2004
- Review
- 26 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K861904 (1986). 10 ancestors in all, the oldest K790187 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 4 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 3 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 1 generation backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- This deviceK040279 Vivaring Microwave Ablation ProbeVivant Medical, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK081042 Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008
- Descendant · 2 generations on · 1 of its ownK100786 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 3 of 3 · See all- K081042Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp. · 2008 · cites it directly2descendants
- K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp. · 2010 · 2 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| −5 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −4 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −3 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −1 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| 0 (this device) | K040279 | Vivaring Microwave Ablation Probe | Vivant Medical, Inc. | 2004 | — |
| +1 | K081042 | Microthermx-100 Microwave Ablation System and Accessories | Bsd Medical Systems Corp. | 2008 | — |
| +2 | 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 |
| 1986 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K023311 | Loop Microwave Ablation ProbeSummary page 1…for coagulation of soft tissue. Not for use in cardiac procedures. Predicate Devices Loop TM Microwave Ablation Probe K02331 1 VivaTip TMMicrowave Ablation Probe K032702 Device Description The VivaRingiTM… | 2003 |
| * | K032702 | Vivatip Microwave Ablation ProbeSummary page 1…Devices Loop TM Microwave Ablation Probe K02331 1 VivaTip TMMicrowave Ablation Probe K032702 Device Description The VivaRingiTM Microwave Ablation Probe consists of a pre-shaped curved microwave antenna wh… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K081042 (Bsd Medical Systems Corp., 2008) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K023311.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The VivaRingTM 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.
https://510kreport.com/device/K040279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040279: Vivaring 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/K040279
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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