510(k) · Cleared
ClearedMicrowave Ablation Generator (KY-2000A, KY-2100A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canyon Medical, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Sep 26, 2024 as substantially equivalent to K201262 (Nanjing Eco Microwave System Co., Ltd., 2021) after a 94-day review. Its family tree reaches back 12 generations to 1987.
- Decided
- Sep 26, 2024
- Review
- 94 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K870028 (1987). 44 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 deviceK241827 Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc. · 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 deviceK241827 Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc. · 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) | K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | 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 |
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 |
|---|---|---|---|
| * | K201262 | Microwave Therapeutic SystemSummary page 5…II Product Code: NEY 5. Predicate Device(s) Information Manufacturer: Nanjing ECO Microwave System Co., Ltd. 510(K) Number: K201262 Trade Name: Microwave Therapeutic System Review Panel: General & Plastic Surgery Regulation Number:… | 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 44 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?
Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue.
The device is not intended for cardiac use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241827: Microwave Ablation Generator (KY-2000A, KY-2100A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241827
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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