510(k) · Cleared
Recalled · Class II · 2017Acculis ACCU2I Pmta Applicator Model ACCU2I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microsulis Medical Limited · NEY System, Ablation, Microwave And Accessories
Cleared on Aug 6, 2010 after a 219-day review. The FDA summary names no predicate by number. 6 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 6, 2010
- Review
- 219 days
- Class
- Class II
- Product code
- NEY
- Recalls
- 6
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK094021 Acculis ACCU2I Pmta Applicator Model ACCU2IMicrosulis Medical Limited · 2010
- Descendant · cites it directly · 5 of its ownK122762 Acculis ACCU21 Pmta Microwave Tissue Ablation ApplicatorMicrosulis Medical Limited · 2012
- Descendant · 2 generations on · 4 of its ownK162449 Solero MTA System, Solero Microwave Tissue Ablation Applicator…AngioDynamics, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK213067 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK223581 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK221883 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122762Acculis ACCU21 Pmta Microwave Tissue Ablation ApplicatorMicrosulis Medical Limited · 2012 · cites it directly5descendants
- K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave…AngioDynamics, Inc. · 2017 · 2 generations on4descendants
- K213067Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021 · 3 generations on2descendants
- K223581Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023 · 4 generations on0descendants
- K221883Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K094021 | Acculis ACCU2I Pmta Applicator Model ACCU2I | Microsulis Medical Limited | 2010 | — |
| +1 | 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 |
| +3 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2021 | — |
| +4 | K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
| +3 | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122762 | Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator | 2012 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2017 | Class II | Z-0529-2018 | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results… |
| Jun 5, 2017 | Class II | Z-0531-2018 | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results… |
| Jun 5, 2017 | Class II | Z-0526-2018 | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results… |
| Jun 5, 2017 | Class II | Z-0528-2018 | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results… |
| Jun 5, 2017 | Class II | Z-0527-2018 | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results… |
| Jun 5, 2017 | Class II | Z-0530-2018 | Under Investigation by firm | The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122762 (Microsulis Medical Limited, 2012) has gone furthest, with 5 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. 2010, 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 Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the
intraoperative coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094021 · printed Nov 5, 2026
Cite this page
510(k) Report. “K094021: Acculis ACCU2I Pmta Applicator Model ACCU2I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K094021
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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