510(k) · Cleared
ClearedEmprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · NEY System, Ablation, Microwave And Accessories
Cleared on Feb 13, 2020 as substantially equivalent to K133821 (Covidien, LLC, 2014) and 2 other predicates after an 80-day review. Its family tree reaches back 12 generations to 1987. 4 later devices descend from it.
- Decided
- Feb 13, 2020
- Review
- 80 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K870028 (1987). 44 ancestors in all, the oldest K811390 (1981). 4 later devices descend from it, 1 citing it directly.
- 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 backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- 1 generation backK171358 Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017
- This deviceK193232 Emprint Ablation System with Thermosphere Technology, Emprint SX…Covidien, LLC · 2020
- Descendant · cites it directly · 3 of its ownK200796 Emprint Ablation System with Thermosphere TechnologyCovidien, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK240480 IntelliBlate Microwave Ablation System Console (IB-CON)…Varian Medical Systems, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK240784 Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233838 Emprint Ablation System with Thermosphere Technology (Overall System…Medtronic, 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 backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- 1 generation backK171358 Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017
- This deviceK193232 Emprint Ablation System with Thermosphere Technology, Emprint SX…Covidien, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC · 2020 · cites it directly3descendants
- K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc. · 2024 · 2 generations on0descendants
- K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc. · 2024 · 2 generations on0descendants
- K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc. · 2024 · 2 generations on0descendants
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 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| −1 | K171358 | Emprint SX Ablation Platform and Accessories | Coviden, LLC | 2017 | — |
| 0 (this device) | K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation… | Covidien, LLC | 2020 | — |
| +1 | K200796 | Emprint Ablation System with Thermosphere Technology | Covidien, LLC | 2020 | — |
| +2 | K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate… | Varian Medical Systems, Inc. | 2024 | — |
| +2 | K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | 2024 | — |
| +2 | K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name)… | Medtronic, 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 3 | 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? (3)
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 5…vice Name Classification Name and Class 510(k) Clearance No. Emprint™ Ablation System with System, Ablation, Microwave and K133821 Thermosphere™ Technology Accessories; Class II Emprint™ Ablation System with System, Ablation, Microwave and… | 2014 |
| * | K163105 | Emprint Ablation SystemSummary page 5…tion, Microwave and K133821 Thermosphere™ Technology Accessories; Class II Emprint™ Ablation System with System, Ablation, Microwave and K163105 Thermosphere™ Technology Accessories; Class II Emprint™ SX Ablation Platform System, Ablation, Microwave and… | 2016 |
| * | K171358 | Emprint SX Ablation Platform and AccessoriesSummary page 5…tion, Microwave and K163105 Thermosphere™ Technology Accessories; Class II Emprint™ SX Ablation Platform System, Ablation, Microwave and K171358 with Thermosphere™ Technology Accessories; Class II IV. Device description The Emprint™ Ablation System with Thermosph… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200796 | Emprint Ablation System with Thermosphere Technology | 2020 | 3 |
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 44 ancestors have a recall of any class.
- Of its descendants, K200796 (Covidien, LLC, 2020) has gone furthest, with 3 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. 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 Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. The EmprintTM Ablation System is not intended for use in cardiac procedures. The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of…
Read the full statement (164 words)
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
The EmprintTM Ablation System is not intended for use in cardiac procedures.
The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures.
The system’s optional, 3-D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193232: Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193232
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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