510(k) · Cleared
Recalled · Class II · 2018Emprint Ablation System
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 Dec 6, 2016 as substantially equivalent to K133821 (Covidien, LLC, 2014) after a 29-day review. Its family tree reaches back 10 generations to 1987. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 6, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- NEY
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 10 generations to K870028 (1987). 42 ancestors in all, the oldest K811390 (1981). 13 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 6 generations between
- 3 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 2 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- This deviceK163105 Emprint Ablation SystemCovidien, LLC · 2016
- Descendant · cites it directly · 6 of its ownK171358 Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017
- Descendant · cites it directly · 4 of its ownK193232 Emprint Ablation System with Thermosphere Technology, Emprint SX…Covidien, LLC · 2020
- Descendant · 2 generations on · 3 of its ownK200796 Emprint Ablation System with Thermosphere TechnologyCovidien, LLC · 2020
- Descendant · cites it directly · 2 of its ownK200298 ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK223138 AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 9 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 8 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 7 generations backK021329 Rita SystemRita Medical Systems · 2002
- 6 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 5 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 4 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 3 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 2 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 1 generation backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- This deviceK163105 Emprint Ablation SystemCovidien, LLC · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017 · cites it directly6descendants
- K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC · 2020 · cites it directly4descendants
- K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC · 2020 · 2 generations on3descendants
- K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2021 · cites it directly2descendants
- K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −9 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −8 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −7 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −6 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −5 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −4 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −3 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −1 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| 0 (this device) | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | — |
| +1 | K171358 | Emprint SX Ablation Platform and Accessories | Coviden, LLC | 2017 | — |
| +1 | K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation… | Covidien, LLC | 2020 | — |
| +2 | K200796 | Emprint Ablation System with Thermosphere Technology | Covidien, LLC | 2020 | — |
| +1 | K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2021 | — |
| +2 | K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K133821 | Emprint Ablation SystemSummary page 4…y Class: II Product Code: NEY III. PREDICATE DEVICE Emprint™ Ablation System with Thermosphere™ Technology, K133821 Modification to System Accessory: Emprint™ Percutaneous Antenna with Thermosphere™ Technology: Cat… | 2014 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171358 | Emprint SX Ablation Platform and Accessories | 2017 | 6 |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with… | 2020 | 4 |
| K200298 | ABI Instrument, Creo Electrosurgical System | 2021 | 2 |
| K200003 | NP1 Instrument, Creo Electrosurgical System | 2020 | 1 |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint… | 2024 | 0 |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2018 | Class II | Z-0625-2019 | Nonconforming Material/Component | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Nov 15, 2018 | Class II | Z-0627-2019 | Nonconforming Material/Component | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
| Nov 15, 2018 | Class II | Z-0626-2019 | Nonconforming Material/Component | The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 42 ancestors have a recall of any class.
- Of its descendants, K171358 (Coviden, LLC, 2017) has gone furthest, with 6 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. 2016, 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 non-resectable liver tumors.
The Emprint Ablation System is not intended for use in cardiac procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163105: Emprint Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163105
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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