510(k) · Cleared
ClearedModel E2517 and Model E2503 Power Control Pencils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 20, 1986 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 20, 1986
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK861112 Model E2517 and Model E2503 Power Control PencilsValleylab, Inc. · 1986
- Descendant · cites it directly · 2 of its ownK051627 Valleylab G3000 Electrosurgical InstrumentValleylab · 2005
- Descendant · cites it directly · 1 of its ownK993009 Hydrocision Arthrojet System with CauteryHydrocision, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK150735 Force TriVerse Electrosugical Device, Holster, 10-foot, Force…Covidien · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
- Descendant · 2 generations on · 0 of its ownK031406 Exojet Tissue Management SystemMitek Worldwide · 2003
Most influential descendants
Showing 5 of 5 · See all- K051627Valleylab G3000 Electrosurgical InstrumentValleylab · 2005 · cites it directly2descendants
- K993009Hydrocision Arthrojet System with CauteryHydrocision, Inc. · 1999 · cites it directly1descendant
- K150735Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical…Covidien · 2015 · 2 generations on0descendants
- K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · cites it directly0descendants
- K031406Exojet Tissue Management SystemMitek Worldwide · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861112 | Model E2517 and Model E2503 Power Control Pencils | Valleylab, Inc. | 1986 | — |
| +1 | K051627 | Valleylab G3000 Electrosurgical Instrument | Valleylab | 2005 | — |
| +1 | K993009 | Hydrocision Arthrojet System with Cautery | Hydrocision, Inc. | 1999 | — |
| +2 | K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse… | Covidien | 2015 | 2 |
| +1 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
| +2 | K031406 | Exojet Tissue Management System | Mitek Worldwide | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K051627 (Valleylab, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K861112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861112: Model E2517 and Model E2503 Power Control Pencils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861112
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026