510(k) · Cleared
ClearedCROMA Electrosurgical Generator (PRD-EMR-050)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creo Medical, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 5, 2025 as substantially equivalent to K230328 (Creo Medical, Ltd., 2023) and 1 other predicate after a 132-day review. Its family tree reaches back 13 generations to 1987.
- Decided
- Feb 5, 2025
- Review
- 132 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K870028 (1987). 46 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 9 generations between
- 3 generations backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- 2 generations backK200298 ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2021
- 1 generation backK223138 AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2023
- This deviceK242983 CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 12 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 11 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 10 generations backK021329 Rita SystemRita Medical Systems · 2002
- 9 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 8 generations backK053290 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- 7 generations backK072687 Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2008
- 6 generations backK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- 5 generations backK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- 4 generations backK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- 3 generations backK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- 2 generations backK200298 ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2021
- 1 generation backK223138 AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd. · 2023
- This deviceK242983 CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −12 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −11 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −10 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −9 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −8 | K053290 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| −7 | K072687 | Valleylab Microwave Ablation Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2008 | — |
| −6 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| −5 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| −4 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| −3 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| −2 | K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2021 | — |
| −1 | K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023 | — |
| 0 (this device) | 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 |
| 2023 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K230328 | Speedboat Flush SB1 InstrumentSummary page 5…Electrosurgical, Cutting & Coagulation & Accessories Regulation Number 878.4400 Product Code(s) GEI, NEY, KNS LEGALLY MARKETED PREDICATE DEVICES K230328 Speedboat Flush SB1 Instrument with Croma Electrosurgical Generator, Product Code KNS K223138 AB1 Electrosurg… | 2023 |
| * | K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical SystemSummary page 5…e(s) GEI, NEY, KNS LEGALLY MARKETED PREDICATE DEVICES K230328 Speedboat Flush SB1 Instrument with Croma Electrosurgical Generator, Product Code KNS K223138 AB1 Electrosurgical Instrument, Creo Electrosurgical System, Product Code NEY DEVICE DESCRIPTION SUMMARY The CROMA Ele… | 2023 |
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 38 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 46 ancestors have a recall of any class.
- 2 other devices also cite its predicate K230328.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
The Reusable Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave (MW) energy for the cutting, coagulation and ablation of tissue via endoscopic access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242983: CROMA Electrosurgical Generator (PRD-EMR-050).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242983
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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