510(k) · Cleared
ClearedDisposable Microwave Therapeutic Antennas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Eco Microwave System Co., Ltd. · NEY System, Ablation, Microwave And Accessories
Cleared on Jul 23, 2021 as substantially equivalent to K183153 (Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., 2019) after a 438-day review. Its family tree reaches back 11 generations to 1987. 4 later devices descend from it.
- Decided
- Jul 23, 2021
- Review
- 438 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K870028 (1987). 43 ancestors in all, the oldest K811390 (1981). 4 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 7 generations between
- 3 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 2 generations backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- 1 generation backK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- This deviceK201265 Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK232241 Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608…Betters (Suzhou) Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK253771 Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3…Nanjing Devin Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241825 Microwave Ablation AntennasCanyon Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233140 Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation…Hygea Medical Technology Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 10 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 9 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 8 generations backK021329 Rita SystemRita Medical Systems · 2002
- 7 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 6 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 5 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 4 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 3 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 2 generations backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- 1 generation backK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- This deviceK201265 Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd. · 2023 · cites it directly1descendant
- K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K241825Microwave Ablation AntennasCanyon Medical, Inc. · 2024 · cites it directly0descendants
- K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −10 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −9 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −8 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −7 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −6 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −5 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −4 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −3 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −2 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| −1 | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
| 0 (this device) | K201265 | Disposable Microwave Therapeutic Antennas | Nanjing Eco Microwave System Co., Ltd. | 2021 | — |
| +1 | K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815… | Betters (Suzhou) Medical Co., Ltd. | 2023 | — |
| +2 | K253771 | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4… | Nanjing Devin Medical Technology Co., Ltd. | 2026 | — |
| +1 | K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | 2024 | — |
| +1 | K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe… | Hygea Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K183153 | Microwave Ablation SystemSummary page 5…evice and accessories Regulation Class: Class II Product Code: NEY 3. Predicate Device Predicate device: 510(K) number: K183153 Device Common Microwave ablation system and accessories Name: Device Trade Microwave Ablati… | 2019 |
| † | K133821 | Emprint Ablation System | 2014 |
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)
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 34 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 43 ancestors have a recall of any class.
- Of its descendants, K232241 (Betters (Suzhou) Medical Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K183153.
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. 2021, 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?
Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended 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/K201265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201265: Disposable Microwave Therapeutic Antennas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201265
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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