510(k) · Cleared
ClearedAB1 Electrosurgical Instrument, Creo Electrosurgical System
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 Jun 26, 2023 as substantially equivalent to K200298 (Creo Medical, Ltd., 2021) after a 265-day review. Its family tree reaches back 12 generations to 1987. 1 later device descends from it.
- Decided
- Jun 26, 2023
- Review
- 265 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). 1 later device descends 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 backK200298 ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2021
- This deviceK223138 AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK242983 CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd. · 2025
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 backK200298 ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2021
- This deviceK223138 AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd. · 2025 · cites it directly0descendants
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 | K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2021 | — |
| 0 (this device) | K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023 | — |
| +1 | K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200298 | ABI Instrument, Creo Electrosurgical SystemSummary page 4…Name: Electrosurgical cutting and coagulation device and accessories Regulation number: CFR 878.4400 Product Code: NEY (Class II) 3.PREDICATE DEVICE K200298 – Creo Electrosurgical System with AB1 Accessory… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | 2025 | 0 |
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 2.5 years on median.
- 9 of the 44 ancestors have a recall of any class.
- Of its descendants, K242983 (Creo Medical, Ltd., 2025) has gone furthest, with 0 descendants of its own.
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 AB1 Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The AB1 Instrument is not intended for use in cardiac procedures.
The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.
The System is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223138
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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