510(k) · Cleared
ClearedAcculis ACCU21 Pmta Microwave Tissue Ablation Applicator
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 Nov 30, 2012 as substantially equivalent to K094021 (Microsulis Medical Limited, 2010) after an 81-day review. Its family tree reaches back 1 generation to 2010. 5 later devices descend from it.
- Decided
- Nov 30, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K094021 (2010). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK094021 Acculis ACCU2I Pmta Applicator Model ACCU2IMicrosulis Medical Limited · 2010 · Recalled
- This deviceK122762 Acculis ACCU21 Pmta Microwave Tissue Ablation ApplicatorMicrosulis Medical Limited · 2012
- Descendant · cites it directly · 4 of its ownK162449 Solero MTA System, Solero Microwave Tissue Ablation Applicator…AngioDynamics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK213067 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK223581 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK221883 Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK182250 Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation…AngioDynamics, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave…AngioDynamics, Inc. · 2017 · cites it directly4descendants
- K213067Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2021 · 2 generations on2descendants
- K223581Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023 · 3 generations on0descendants
- K221883Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc. · 2023 · 2 generations on0descendants
- K182250Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm)…AngioDynamics, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K094021 | Acculis ACCU2I Pmta Applicator Model ACCU2I | Microsulis Medical Limited | 2010 | 6 |
| 0 (this device) | K122762 | Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator | Microsulis Medical Limited | 2012 | — |
| +1 | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero… | AngioDynamics, Inc. | 2017 | 9 |
| +2 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2021 | — |
| +3 | K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
| +2 | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K094021 | Acculis ACCU2I Pmta Applicator Model ACCU2ISummary page 1…substantial equivalence is claimed Acculis Accu2i pMTA Microwave Tissue Ablation Applicator and SuIiSVPMTA Generator Premarket Clearance - K094021 Stsepen I Mos Sre, Gwafoo62 1L… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave… | 2017 | 4 |
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?
- Its one ancestor has a recall.
- Of its descendants, K162449 (AngioDynamics, Inc., 2017) has gone furthest, with 4 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. 2012, 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?
Acculis Accu2i pMVTA Applicator with SuIiSVM1TA Generator software release 2.1.0 is indicated for the intraoperative coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122762: Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122762
Report an extraction error
Are you the manufacturer?
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