510(k) · Cleared
ClearedE2508 Disposable Handswitching Pencil
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 Nov 10, 1981 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Nov 10, 1981
- Review
- 8 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK813071 E2508 Disposable Handswitching PencilValleylab, Inc. · 1981
- Descendant · cites it directly · 3 of its ownK152219 PK AIMGyrus Acmi, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK111285 Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with…Salient Surgical Technologies, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK051627 Valleylab G3000 Electrosurgical InstrumentValleylab · 2005
- Descendant · 3 generations on · 1 of its ownK163373 PK AIMGyrus Acmi, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K152219PK AIMGyrus Acmi, Inc. · 2015 · cites it directly3descendants
- K111285Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc. · 2011 · cites it directly3descendants
- K161825PK AIMGyrus Acmi, Inc. · 2016 · 2 generations on2descendants
- K051627Valleylab G3000 Electrosurgical InstrumentValleylab · 2005 · cites it directly2descendants
- K163373PK AIMGyrus Acmi, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K813071 | E2508 Disposable Handswitching Pencil | Valleylab, Inc. | 1981 | — |
| +1 | K152219 | PK AIM | Gyrus Acmi, Inc. | 2015 | — |
| +1 | K111285 | Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting | Salient Surgical Technologies, Inc. | 2011 | 1 |
| +2 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +1 | K051627 | Valleylab G3000 Electrosurgical Instrument | Valleylab | 2005 | — |
| +3 | K163373 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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? (11)
See all 113 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, K152219 (Gyrus Acmi, Inc., 2015) has gone furthest, with 3 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/K813071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K813071: E2508 Disposable Handswitching Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K813071
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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