510(k) · Cleared
ClearedMicrowave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygea Medical Technology Co., Ltd. · NEY System, Ablation, Microwave And Accessories
Cleared on Jan 31, 2024 as substantially equivalent to K201262 (Nanjing Eco Microwave System Co., Ltd., 2021) and 1 other predicate after a 126-day review. Its family tree reaches back 12 generations to 1987.
- Decided
- Jan 31, 2024
- Review
- 126 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K870028 (1987). 45 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 8 generations between
- 3 generations backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- 2 generations backK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- 1 generation backK201262 Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. · 2021
- This deviceK233140 Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation…Hygea Medical Technology Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 11 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 10 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 9 generations backK021329 Rita SystemRita Medical Systems · 2002
- 8 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 7 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 6 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 5 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 4 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 3 generations backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- 2 generations backK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- 1 generation backK201262 Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. · 2021
- This deviceK233140 Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation…Hygea Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −11 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −10 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −9 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −8 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −7 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −6 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −5 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −4 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −3 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| −2 | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
| −1 | K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | 2021 | — |
| 0 (this device) | 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 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K201262 | Microwave Therapeutic SystemSummary page 5…s): NEY Class: II Classification Panel: General & Plastic Surgery 4. Legally Marketed Predicate Device(s): Microwave Therapeutic System (K201262) Disposable Microwave Therapeutic Antennas (K201265) Manufacturer: Nanjing ECO Microwave System Co., Ltd.… | 2021 |
| * | K201265 | Disposable Microwave Therapeutic AntennasSummary page 5…fication Panel: General & Plastic Surgery 4. Legally Marketed Predicate Device(s): Microwave Therapeutic System (K201262) Disposable Microwave Therapeutic Antennas (K201265) Manufacturer: Nanjing ECO Microwave System Co., Ltd. Page 1… | 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 37 years and passes through 9 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 45 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201262.
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. 2024, 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 indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.
Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233140: Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233140
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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