510(k) · Cleared
ClearedGeiger Electrosurgical Handpiece Sheath, Model 405
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geiger Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 19, 1999 as substantially equivalent to K963088 (Aspen Laboratories, Inc., 1996) after a 56-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Aug 19, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963088 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK963088 Sheath, Electrosurgical PencilAspen Laboratories, Inc. · 1996 · Recalled
- This deviceK992149 Geiger Electrosurgical Handpiece Sheath, Model 405Geiger Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK011929 Handpiece Sheath-Model #A910Aaron Medical, Inc. · 2001
Most influential descendants
Showing 1 of 1 · See all- K011929Handpiece Sheath-Model #A910Aaron Medical, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963088 | Sheath, Electrosurgical Pencil | Aspen Laboratories, Inc. | 1996 | 5 |
| 0 (this device) | K992149 | Geiger Electrosurgical Handpiece Sheath, Model 405 | Geiger Medical Technologies, Inc. | 1999 | — |
| +1 | K011929 | Handpiece Sheath-Model #A910 | Aaron Medical, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K963088 | Sheath, Electrosurgical PencilSummary page 1…substantially equivalent to the ConMed Non-Sterile Handpiece Sheath (510(k) clearance information unknown), and to the ConMed Sterile Handpiece Sheath, FDA-cleared under K963088. The Geiger Electrosurgical Handpiece Sheath is substantially equivalent to the listed devices in design, operation, intended use… | 1996 |
| * | — | ConMed Non-Sterile Handpiece Sheath Named without a submission number | |
| † | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011929 | Handpiece Sheath-Model #A910 | 2001 | 0 |
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?
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 Geiger Electrosurgical Handpiece Sheath is intended to be placed over an electrosurgical handpiece and act as a non-sterile protective barrier between the electrosurgical handpiece and the patient. The sheath is not intended to alter functionality of electrosurgical handpieces utilized in surgery.
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/K992149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992149: Geiger Electrosurgical Handpiece Sheath, Model 405.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992149
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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