510(k) · Cleared
ClearedHEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galil Medical, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Jul 9, 2020 as substantially equivalent to K133821 (Covidien, LLC, 2014) and 1 other predicate after a 178-day review. Its family tree reaches back 11 generations to 1987.
- Decided
- Jul 9, 2020
- Review
- 178 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K870028 (1987). 43 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- 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 backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- This deviceK200061 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System…Galil Medical, Inc. · 2020
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 backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- This deviceK200061 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System…Galil Medical, Inc. · 2020
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 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| 0 (this device) | K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart… | Galil Medical, Inc. | 2020 | — |
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? (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 |
|---|---|---|---|
| * | K133821 | Emprint Ablation SystemSummary page 4…ries Regulation Number: 21 CFR 878.4400 Product Code: NEY Predicate Devices: Emprint Ablation System (K133821) Emprint Ablation System (K163105) Reference Devices: Multi-Point Th… | 2014 |
| * | K163105 | Emprint Ablation SystemSummary page 4…Product Code: NEY Predicate Devices: Emprint Ablation System (K133821) Emprint Ablation System (K163105) Reference Devices: Multi-Point Thermal Sensor (K060390) Date of Preparation: July 7, 202… | 2016 |
| † | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | 2006 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 43 ancestors have a recall of any class.
- 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. 2020, 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 HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.
The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200061 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200061: HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200061
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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