510(k) · Cleared
Recalled · Class II · 2021Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on May 5, 2017 as substantially equivalent to K122762 (Microsulis Medical Limited, 2012) after a 246-day review. Its family tree reaches back 2 generations to 2010. 4 later devices descend from it. It has been recalled 9 times.
- Decided
- May 5, 2017
- Review
- 246 days
- Class
- Class II
- Product code
- NEY
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 2 generations to K094021 (2010). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK094021 Acculis ACCU2I Pmta Applicator Model ACCU2IMicrosulis Medical Limited · 2010 · Recalled
- 1 generation backK122762 Acculis ACCU21 Pmta Microwave Tissue Ablation ApplicatorMicrosulis Medical Limited · 2012
- This deviceK162449 Solero MTA System, Solero Microwave Tissue Ablation Applicator…AngioDynamics, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK213067 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK223581 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK221883 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK182250 Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation…AngioDynamics, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K213067Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021 · cites it directly2descendants
- K223581Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023 · 2 generations on0descendants
- K221883Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023 · cites it directly0descendants
- K182250Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm)…AngioDynamics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K094021 | Acculis ACCU2I Pmta Applicator Model ACCU2I | Microsulis Medical Limited | 2010 | 6 |
| −1 | K122762 | Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator | Microsulis Medical Limited | 2012 | — |
| 0 (this device) | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero… | AngioDynamics, Inc. | 2017 | — |
| +1 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2021 | — |
| +2 | K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
| +1 | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
| +1 | K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation… | AngioDynamics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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? (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.
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2021 | Class II | Z-2436-2021 | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| Jul 20, 2021 | Class II | Z-2439-2021 | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| Jul 20, 2021 | Class II | Z-2438-2021 | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| Jul 20, 2021 | Class II | Z-2437-2021 | Software design | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up. |
| Apr 17, 2019 | Class II | Z-1701-2019 | Device Design | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| Apr 17, 2019 | Class II | Z-1700-2019 | Device Design | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| Apr 17, 2019 | Class II | Z-1703-2019 | Device Design | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| Apr 17, 2019 | Class II | Z-1704-2019 | Device Design | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
| Apr 17, 2019 | Class II | Z-1702-2019 | Device Design | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K213067 (AngioDynamics, Inc., 2021) has gone furthest, with 2 descendants of its own.
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. 2017, 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 Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures.
The Solero MTA System is not indicated for cardiac use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162449: Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162449
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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