510(k) · Cleared
ClearedMicrowave Tissue Coagulation System (MTCS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foundry Newco X, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Jan 14, 2008 as substantially equivalent to K011676 (Vivant Medical, Inc., 2002) and 4 other predicates after a 97-day review. Its family tree reaches back 6 generations to 1986. 11 later devices descend from it.
- Decided
- Jan 14, 2008
- Review
- 97 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K861904 (1986). 19 ancestors in all, the oldest K790187 (1979). 11 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK861904 HS-15M Microwave Surgery Equipment, MicrotazeCooper Lasersonics, Inc. · 1986
- 5 generations backK011676 Vivawave Microwave SystemVivant Medical, Inc. · 2002 · Recalled
- 4 generations backK023311 Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 3 generations backK032047 Tri-Loop Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 2 generations backK032702 Vivatip Microwave Ablation ProbeVivant Medical, Inc. · 2003
- 1 generation backK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
- This deviceK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
- Descendant · cites it directly · 3 of its ownK181941 Swift SystemEmblation, Ltd. · 2018
- Descendant · 3 generations on · 3 of its ownK131162 Miradry SystemMiramar Labs, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK222388 swiftPro SystemEmblation, Ltd. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · cites it directly10descendants
- K103014Miradry SystemMiramar Labs, Inc. · 2011 · 2 generations on5descendants
- K181941Swift SystemEmblation, Ltd. · 2018 · cites it directly3descendants
- K131162Miradry SystemMiramar Labs, Inc. · 2013 · 3 generations on3descendants
- K222388swiftPro SystemEmblation, Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861904 | HS-15M Microwave Surgery Equipment, Microtaze | Cooper Lasersonics, Inc. | 1986 | — |
| −5 | K011676 | Vivawave Microwave System | Vivant Medical, Inc. | 2002 | 1 |
| −4 | K023311 | Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −3 | K032047 | Tri-Loop Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −2 | K032702 | Vivatip Microwave Ablation Probe | Vivant Medical, Inc. | 2003 | — |
| −1 | K052919 | Microsulis Tissue Ablation System | Microsulis Americas, Inc. | 2006 | — |
| 0 (this device) | K072870 | Microwave Tissue Coagulation System (MTCS) | Foundry Newco X, Inc. | 2008 | — |
| +1 | K082819 | Dermatologic Treatment System (DTS) G2 | Miramar Labs, Inc. | 2009 | — |
| +2 | K103014 | Miradry System | Miramar Labs, Inc. | 2011 | 2 |
| +1 | K181941 | Swift System | Emblation, Ltd. | 2018 | — |
| +3 | K131162 | Miradry System | Miramar Labs, Inc. | 2013 | 1 |
| +2 | K222388 | swiftPro System | Emblation, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K011676 | Vivawave Microwave SystemSummary page 1…f Technology Officer Intended Use The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue. Predicate Devices K0 11676 VivaWave Microwave Ablation System K052919 Microsulis MTA System K984552 Radionics Cool-T… | 2002 |
| * | K052919 | Microsulis Tissue Ablation SystemSummary page 1…issue Coagulation System (MTCS) is intended for coagulation of soft tissue. Predicate Devices K0 11676 VivaWave Microwave Ablation System K052919 Microsulis MTA System K984552 Radionics Cool-Tip RF System K021368 Medela Vacuum Pump Mo… | 2006 |
| * | K984552 | Cool-Tip RF SystemSummary page 1…r coagulation of soft tissue. Predicate Devices K0 11676 VivaWave Microwave Ablation System K052919 Microsulis MTA System K984552 Radionics Cool-Tip RF System K021368 Medela Vacuum Pump Model 30 K003978 AFX Microwave G… | 1999 |
| * | K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Summary page 1…ces K0 11676 VivaWave Microwave Ablation System K052919 Microsulis MTA System K984552 Radionics Cool-Tip RF System K021368 Medela Vacuum Pump Model 30 K003978 AFX Microwave Generator Device Description The Microwave… | 2002 |
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 1…tion System K052919 Microsulis MTA System K984552 Radionics Cool-Tip RF System K021368 Medela Vacuum Pump Model 30 K003978 AFX Microwave Generator Device Description The Microwave Tissue Coagulation System (MTCS) is designed to coag… | 2001 |
What descends from it? (11)
See all 112 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 22 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K082819 (Miramar Labs, Inc., 2009) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K011676.
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. 2008, 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 Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072870: Microwave Tissue Coagulation System (MTCS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072870
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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