510(k) · Cleared
Recalled · 2009Midas Touch Electrosurgical Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iti Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 27, 1997 as substantially equivalent to K903302 (Megadyne Medical Products, Inc., 1990) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1990. It has been recalled 2 times.
- Decided
- Oct 27, 1997
- Review
- 60 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903302 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK903302 Electrode, ElectrosurgeryMegadyne Medical Products, Inc. · 1990
- This deviceK973234 Midas Touch Electrosurgical ElectrodeIti Medical Technologies, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903302 | Electrode, Electrosurgery | Megadyne Medical Products, Inc. | 1990 | — |
| 0 (this device) | K973234 | Midas Touch Electrosurgical Electrode | Iti Medical Technologies, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K903302 | Electrode, ElectrosurgerySummary page 1…accessories 21 CFR § 878.4400 Class and Panel: Regulatory Class II Product Code: GEI General and Plastic Surgery 79 Predicate Devices: MegaDyne Medical Products, Inc. K903302 Aaron Medical Industries, Inc. K913623 Description of Device: The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical El… | 1990 |
| * | K913623 | Surgical Electrical PencilSummary page 1…nd Panel: Regulatory Class II Product Code: GEI General and Plastic Surgery 79 Predicate Devices: MegaDyne Medical Products, Inc. K903302 Aaron Medical Industries, Inc. K913623 Description of Device: The ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are similar in design to the p… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2009 | Not classified | Z-0140-2010 | Process control | THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND… |
| Aug 29, 2006 | Not classified | Z-0182-2007 | Other | Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K903302.
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 ITI Medical Technologies, Inc. Midas Touch™ Electrosurgical Electrodes are intended for use in standard electrosurgical chucks and pencil type accessories wherever standard monopolar electrosurgical cutting and coagulation electrodes are used.
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/K973234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973234: Midas Touch Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973234
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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