510(k) · Cleared
ClearedUnimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip Cleaner, Unimed Disposable Hand and F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimed Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 16, 1999 after an 18-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Nov 16, 1999
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK993647 Unimed Disposable Hand and Foot-Switching Pencils with Holster and…Unimed Surgical Products, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK092634 Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DFJiangmen City Xinhui Baisheng Medical Equipment CO · 2009
- Descendant · 2 generations on · 0 of its ownK170369 Disposable Electrosurgical PencilsCathay Manfacturing Corp. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993647 | Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and… | Unimed Surgical Products, Inc. | 1999 | — |
| +1 | K092634 | Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2009 | — |
| +2 | K170369 | Disposable Electrosurgical Pencils | Cathay Manfacturing Corp. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092634 | Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF | 2009 | 1 |
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, K092634 (Jiangmen City Xinhui Baisheng Medical Equipment CO, 2009) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Electrosurgical Pencils and Electrodes are used for the cutting and coagulation of soft tissue. The Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993647 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993647: Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip Cleaner, Unimed Disposable Hand and F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993647
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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