510(k) · Cleared
ClearedSolero Microwave Tissue Ablation (MTA) System and Accessories
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 Mar 7, 2023 as substantially equivalent to K162449 (AngioDynamics, Inc., 2017) and 1 other predicate after a 251-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Mar 7, 2023
- Review
- 251 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K094021 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK094021 Acculis ACCU2I Pmta Applicator Model ACCU2IMicrosulis Medical Limited · 2010 · Recalled
- 3 generations backK122762 Acculis ACCU21 Pmta Microwave Tissue Ablation ApplicatorMicrosulis Medical Limited · 2012
- 2 generations backK162449 Solero MTA System, Solero Microwave Tissue Ablation Applicator…AngioDynamics, Inc. · 2017 · Recalled
- 1 generation backK213067 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021
- This deviceK221883 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K094021 | Acculis ACCU2I Pmta Applicator Model ACCU2I | Microsulis Medical Limited | 2010 | 6 |
| −3 | K122762 | Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator | Microsulis Medical Limited | 2012 | — |
| −2 | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero… | AngioDynamics, Inc. | 2017 | 9 |
| −1 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2021 | — |
| 0 (this device) | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
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? (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 |
|---|---|---|---|
| * | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave…Summary page 4…(21 CFR § 878.4400, Class II, Pro-Code NEY) Classification Panel: General Surgery D. PREDICATE DEVICE 510(k) Number: K162449/K213067 Trade Name: Solero Microwave Tissue Ablation (MTA) System Common/Usual Name: Microwave T… | 2017 |
| * | K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesSummary page 4…(21 CFR § 878.4400, Class II, Pro-Code NEY) Classification Panel: General Surgery D. PREDICATE DEVICE 510(k) Number: K162449/K213067 Trade Name: Solero Microwave Tissue Ablation (MTA) System Common/Usual Name: Microwave Tissue Ab… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K162449.
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. 2023, 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 and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221883: Solero Microwave Tissue Ablation (MTA) System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221883
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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