510(k) · Cleared
ClearedEmprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Mar 28, 2024 as substantially equivalent to K133821 (Covidien, LLC, 2014) and 2 other predicates after a 115-day review. Its family tree reaches back 14 generations to 1987.
- Decided
- Mar 28, 2024
- Review
- 115 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K870028 (1987). 46 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 10 generations between
- 3 generations backK171358 Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017
- 2 generations backK193232 Emprint Ablation System with Thermosphere Technology, Emprint SX…Covidien, LLC · 2020
- 1 generation backK200796 Emprint Ablation System with Thermosphere TechnologyCovidien, LLC · 2020
- This deviceK233838 Emprint Ablation System with Thermosphere Technology (Overall System…Medtronic, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 13 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 12 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 11 generations backK021329 Rita SystemRita Medical Systems · 2002
- 10 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 9 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 8 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 7 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 6 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 5 generations backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- 4 generations backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- 3 generations backK171358 Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017
- 2 generations backK193232 Emprint Ablation System with Thermosphere Technology, Emprint SX…Covidien, LLC · 2020
- 1 generation backK200796 Emprint Ablation System with Thermosphere TechnologyCovidien, LLC · 2020
- This deviceK233838 Emprint Ablation System with Thermosphere Technology (Overall System…Medtronic, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −13 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −12 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −11 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −10 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −9 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −8 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −7 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −6 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −5 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| −4 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| −3 | K171358 | Emprint SX Ablation Platform and Accessories | Coviden, LLC | 2017 | — |
| −2 | K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation… | Covidien, LLC | 2020 | — |
| −1 | K200796 | Emprint Ablation System with Thermosphere Technology | Covidien, LLC | 2020 | — |
| 0 (this device) | 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 |
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…No Emprint™ Ablation System with System, Ablation, Microwave and K133821, K163105, Thermosphere™ Technology Accessories; Class II and K200796 Covidien LLC EmprintT… | 2014 |
| * | K163105 | Emprint Ablation SystemSummary page 5…No Emprint™ Ablation System with System, Ablation, Microwave and K133821, K163105, Thermosphere™ Technology Accessories; Class II and K200796 Covidien LLC EmprintTM Ablatio… | 2016 |
| * | K200796 | Emprint Ablation System with Thermosphere TechnologySummary page 5…on System with System, Ablation, Microwave and K133821, K163105, Thermosphere™ Technology Accessories; Class II and K200796 Covidien LLC EmprintTM Ablation System with ThermosphereTM Technology Special 510(k) Submission… | 2020 |
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 8 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 46 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. 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 Emprint™ ablation system is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.
The Emprint™ ablation system is not intended for use in cardiac procedures.
The Emprint™ ablation system overlapping technique is only intended for use in the liver.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233838: Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233838
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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