510(k) · Cleared
ClearedSterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 18, 2024 as substantially equivalent to K192542 (Modern Medical Equipment Manufacturing, Ltd., 2020) after a 248-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jan 18, 2024
- Review
- 248 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K965054 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK965054 PencilMegadyne Medical Products, Inc. · 1997 · Recalled
- 1 generation backK192542 Foot Control Electrosurgical Pencil, Push Button Electrosurgical…Modern Medical Equipment Manufacturing, Ltd. · 2020
- This deviceK231405 Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode…Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965054 | Pencil | Megadyne Medical Products, Inc. | 1997 | 8 |
| −1 | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil… | Modern Medical Equipment Manufacturing, Ltd. | 2020 | — |
| 0 (this device) | K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile… | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | 2024 | — |
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? (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 |
|---|---|---|---|
| * | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch…Summary page 4…cation Name: 878.4400: Electrosurgical Cutting and Coagulation Device and Accessories Class: II Product Code: GEI 4. Predicate and Reference Devices: Predicate Device: K192542 Single Use Electrosurgical pencil with non-coated and non-stick electrode (Nonsterile and sterile) Reference Device: K170369 Disp… | 2020 |
| † | K170369 | Disposable Electrosurgical Pencils | 2018 |
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 27 years and passes through 3 companies; a new generation was cleared every 23.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K192542.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231405: Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231405
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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