510(k) · Cleared
ClearedAaron TOP50 Reusable Electrosurgical Pencil, Model #Espr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaron Medical Industries · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 4, 1999 as substantially equivalent to K970039 (Medtrex, Inc., 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 4, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914400 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914400 Models E2502B/E2525 Reusable Handswitching PencilsValleylab, Inc. · 1991
- This deviceK984352 Aaron TOP50 Reusable Electrosurgical Pencil, Model #EsprAaron Medical Industries · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914400 | Models E2502B/E2525 Reusable Handswitching Pencils | Valleylab, Inc. | 1991 | — |
| 0 (this device) | K984352 | Aaron TOP50 Reusable Electrosurgical Pencil, Model #Espr | Aaron Medical Industries | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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? (3)
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 |
|---|---|---|---|
| * | K970039 | Encore Electrosurgical Handcontrol Pencil (35001-001)Summary page 1…sterile and is intended for thirty-time reuse. The Aaron Top50 Handcontrol Pencil is equivalent to the Medtrex Encore Electrosurgical Handcontrol Pencil, cleared under K970039 dated February 26, 1997. It is substantially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron… | 1997 |
| * | K914400 | Models E2502B/E2525 Reusable Handswitching PencilsSummary page 1…core Electrosurgical Handcontrol Pencil, cleared under K970039 dated February 26, 1997. It is substantially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron Medical Industries, Inc Model A801 monopolar handpiece cleared under 510(k) K955681in design, operation, intended… | 1991 |
| * | K955681 | Aaron 800 High Frequency Desiccator/HandpieceSummary page 1…antially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron Medical Industries, Inc Model A801 monopolar handpiece cleared under 510(k) K955681in design, operation, intended use, materials, components and performance claims. Testing which has been performed on the Aaron T… | 1996 |
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K970039.
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 Aaron Top50 Reusable Electrosurgical Pencil is intended to be used in general electrosurgical applications for cutting and coagulation during surgical procedures. It is provided non-sterile and is intended for reuse.
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/K984352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984352: Aaron TOP50 Reusable Electrosurgical Pencil, Model #Espr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984352
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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