510(k) · Cleared
ClearedMicrowave Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · NEY System, Ablation, Microwave And Accessories
Cleared on Jul 8, 2019 as substantially equivalent to K133821 (Covidien, LLC, 2014) after a 236-day review. Its family tree reaches back 10 generations to 1987. 9 later devices descend from it.
- Decided
- Jul 8, 2019
- Review
- 236 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K870028 (1987). 42 ancestors in all, the oldest K811390 (1981). 9 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations between
- 3 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 2 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- This deviceK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- Descendant · cites it directly · 4 of its ownK201265 Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK201262 Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK232240 Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK232241 Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608…Betters (Suzhou) Medical Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK252632 Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 9 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 8 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 7 generations backK021329 Rita SystemRita Medical Systems · 2002
- 6 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 5 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 4 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 3 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 2 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- This deviceK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. · 2021 · cites it directly4descendants
- K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. · 2021 · cites it directly4descendants
- K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd. · 2023 · 2 generations on1descendant
- K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd. · 2023 · 2 generations on1descendant
- K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −9 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −8 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −7 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −6 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −5 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −4 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −3 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −1 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| 0 (this device) | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
| +1 | K201265 | Disposable Microwave Therapeutic Antennas | Nanjing Eco Microwave System Co., Ltd. | 2021 | — |
| +1 | K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | 2021 | — |
| +2 | K232240 | Microwave Ablation System (BD-GT) | Betters (Suzhou) Medical Co., Ltd. | 2023 | — |
| +2 | K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815… | Betters (Suzhou) Medical Co., Ltd. | 2023 | — |
| +3 | K252632 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K133821 | Emprint Ablation SystemSummary page 4…ting and coagulation device and accessories Regulation Number: 878.4400 Product Code: NEY Class: II Panel: General & Plastic Surgery 3.3 Predicate Device 510(k) Number: K133821 Common Name: Microwave ablation system and accessories Device Trade/Proprietary Name: EmprintTM Ablation System Classification Na… | 2014 |
What descends from it? (9)
2 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 32 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 42 ancestors have a recall of any class.
- Of its descendants, K201265 (Nanjing Eco Microwave System Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K133821.
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. 2019, 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 Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183153: Microwave Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183153
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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