510(k) · Cleared
ClearedAaron Reusable Electrosurgical Electrode
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 Feb 25, 2002 as substantially equivalent to K931338 (Aaron Medical Industries, 1994) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Feb 25, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931338 (1994). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931338 16 Electrodes (Blade, Ball, Needle & Loop)Aaron Medical Industries · 1994
- This deviceK014201 Aaron Reusable Electrosurgical ElectrodeAaron Medical Industries · 2002
- Descendant · cites it directly · 1 of its ownK161378 joimax Electrosurgical InstrumentsJoimax GmbH · 2016
- Descendant · cites it directly · 1 of its ownK051956 DR. Oppel ST-501Sometech Incorporated · 2005
- Descendant · 2 generations on · 0 of its ownK211173 maxmorespine Bipolar ElectrodesHoogland Spine Products, GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK134036 Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp · 2015
Most influential descendants
Showing 4 of 4 · See all- K161378joimax Electrosurgical InstrumentsJoimax GmbH · 2016 · cites it directly1descendant
- K051956DR. Oppel ST-501Sometech Incorporated · 2005 · cites it directly1descendant
- K211173maxmorespine Bipolar ElectrodesHoogland Spine Products, GmbH · 2022 · 2 generations on0descendants
- K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931338 | 16 Electrodes (Blade, Ball, Needle & Loop) | Aaron Medical Industries | 1994 | — |
| 0 (this device) | K014201 | Aaron Reusable Electrosurgical Electrode | Aaron Medical Industries | 2002 | — |
| +1 | K161378 | joimax Electrosurgical Instruments | Joimax GmbH | 2016 | — |
| +1 | K051956 | DR. Oppel ST-501 | Sometech Incorporated | 2005 | — |
| +2 | K211173 | maxmorespine Bipolar Electrodes | Hoogland Spine Products, GmbH | 2022 | — |
| +2 | K134036 | Wavetronic 5000 Digital HF Surgical Unit | Loktal Medical Electronics Ind. Com. Ltda- Epp | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K931338 | 16 Electrodes (Blade, Ball, Needle & Loop)Summary page 1…cut and excise tissue or to coagulate blood vessels during surgery. The Aaron Reusable Electrosurgical is substantially equivalent to Aaron Electrosurgical Electrodes (K931338 and K942986) in operation, intended use, energy source, and method of preparation. Performance claims for the reusable electrodes… | 1994 |
| * | K942986 | Electrodes (Blade, Ball, Needle, and Loop)Summary page 1…se tissue or to coagulate blood vessels during surgery. The Aaron Reusable Electrosurgical is substantially equivalent to Aaron Electrosurgical Electrodes (K931338 and K942986) in operation, intended use, energy source, and method of preparation. Performance claims for the reusable electrodes differ from… | 1995 |
What descends from it? (4)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K161378 (Joimax GmbH, 2016) 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?
Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during 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/K014201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014201: Aaron Reusable Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014201
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026