510(k) · Cleared
ClearedCreo Electrosurgical System with NP1 Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creo Medical, Ltd. · NEY System, Ablation, Microwave And Accessories
Cleared on Feb 14, 2023 as substantially equivalent to K200003 (Creo Medical, Ltd., 2020) after a 250-day review. Its family tree reaches back 12 generations to 1987.
- Decided
- Feb 14, 2023
- Review
- 250 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K870028 (1987). 44 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- 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 backK200003 NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2020
- This deviceK221672 Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd. · 2023
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 backK200003 NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2020
- This deviceK221672 Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd. · 2023
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 | K200003 | NP1 Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2020 | — |
| 0 (this device) | K221672 | Creo Electrosurgical System with NP1 Instrument | 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 |
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 |
|---|---|---|---|
| * | K200003 | NP1 Instrument, Creo Electrosurgical SystemSummary page 4…ulation device and accessories Regulation number: CFR 878.4400 Product Code: NEY (Class II) 3. PREDICATE DEVICE K200003 Creo Electrosurgical System with NP1 Accessory Traditional 510(k) Premarket Notifica… | 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 36 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.
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. 2023, 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 NP1 MicroBlate Fine Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. The NP1 MicroBlate Fine Instrument is not intended for use in cardiac procedures. The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue. The Electrosurgical…
Read the full statement (126 words)
The NP1 MicroBlate Fine Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The NP1 MicroBlate Fine Instrument is not intended for use in cardiac procedures.
The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue.
The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical HS1 SlypSeal Instrument, intended for coagulation (hemostasis and cauterization) of soft tissue.
The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to the compatible Creo Medical RS2 Speedboat Instrument, intended for coagulation (hemostasis and cauterization) and cutting soft tissue.
The Electrosurgical System is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221672: Creo Electrosurgical System with NP1 Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221672
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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