510(k) · Cleared
Recalled · Class II · 2017Emprint 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 Apr 28, 2014 as substantially equivalent to K072687 (Covidien Lp, Formerly Know AS Valleylab, A Divison, 2008) and 1 other predicate after a 133-day review. Its family tree reaches back 9 generations to 1987. 29 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 28, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- NEY
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 9 generations to K870028 (1987). 41 ancestors in all, the oldest K811390 (1981). 29 later devices descend from it, 8 citing it directly.
- Root · 9 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations between
- 3 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 2 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 1 generation backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- This deviceK133821 Emprint Ablation SystemCovidien, LLC · 2014
- Descendant · cites it directly · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- Descendant · cites it directly · 9 of its ownK183153 Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- Descendant · cites it directly · 6 of its ownK171358 Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017
- Descendant · 2 generations on · 4 of its ownK201265 Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK201262 Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 8 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 7 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 6 generations backK021329 Rita SystemRita Medical Systems · 2002
- 5 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 4 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 3 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 2 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 1 generation backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- This deviceK133821 Emprint Ablation SystemCovidien, LLC · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K163105Emprint Ablation SystemCovidien, LLC · 2016 · cites it directly13descendants
- K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019 · cites it directly9descendants
- K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC · 2017 · cites it directly6descendants
- K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd. · 2021 · 2 generations on4descendants
- K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −8 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −7 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −6 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −5 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −4 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −3 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −2 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −1 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| 0 (this device) | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | — |
| +1 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| +1 | K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
| +1 | K171358 | Emprint SX Ablation Platform and Accessories | Coviden, LLC | 2017 | — |
| +2 | K201265 | Disposable Microwave Therapeutic Antennas | Nanjing Eco Microwave System Co., Ltd. | 2021 | — |
| +2 | K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K072687 | Valleylab Microwave Ablation GeneratorSummary page 1…Trade Name: Valleylab Microwave Ablation Generator Device Common Nambe: Microwave ablation system and accessories 5 10(k) Number: K072687 Manufacturer: Covidien Ile Trade Name: Certus 140 2.45 GHz Ablation System and Accessories D… | 2008 |
| * | K113237 | Certus 140 2.45GHZ Ablation SystemSummary page 1…Certus 140 2.45 GHz Ablation System and Accessories Device Common Name: Microwave ablation system and accessories 5 10(k) Number: K1 13237 Manufacturer: NeuWave Medical, Inc. System Description The EmprintTM Ablation System is a microwave-based system… | 2012 |
What descends from it? (29)
See all 298 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163105 | Emprint Ablation System | 2016 | 13 |
| K183153 | Microwave Ablation System | 2019 | 9 |
| K171358 | Emprint SX Ablation Platform and Accessories | 2017 | 6 |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with… | 2020 | 4 |
| K181941 | Swift System | 2018 | 3 |
| 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 |
| K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2017 | Class II | Z-0560-2018 | Device Design | 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. |
| Aug 7, 2017 | Class II | Z-0561-2018 | Device Design | 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. |
| Aug 7, 2017 | Class II | Z-0556-2018 | Device Design | 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. |
| Aug 7, 2017 | Class II | Z-0557-2018 | Device Design | 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. |
| Aug 7, 2017 | Class II | Z-0558-2018 | Device Design | 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. |
| Aug 7, 2017 | Class II | Z-0559-2018 | Device Design | 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. |
| Feb 23, 2016 | Class II | Z-1187-2016 | Nonconforming Material/Component | Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K163105 (Covidien, LLC, 2016) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K072687.
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. 2014, 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 Covidien Emprintw 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 Covidien Emprintrm Ablation System is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133821: 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/K133821
Report an extraction error
Are you the manufacturer?
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