510(k) · Cleared
ClearedSingle Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Medical Equipment Manufacturing Limited · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 28, 2017 as substantially equivalent to K071343 (Ellman International, Inc., 2008) and 1 other predicate after a 294-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 28, 2017
- Review
- 294 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944265 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944265 Needle ElctrodeUnimed Surgical Products, Inc. · 1995 · Recalled
- This deviceK163442 Single Use Micro Electrode (Brass with gold plated shaft); Single…Modern Medical Equipment Manufacturing Limited · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944265 | Needle Elctrode | Unimed Surgical Products, Inc. | 1995 | 11 |
| 0 (this device) | K163442 | Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro… | Modern Medical Equipment Manufacturing Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K071343 | Ellman Noble Alloy ElectrodesSummary page 5…gulate soft tissues by means of high frequency electrical current during an electrosurgical procedure 5. Predicate device Ellman’s Ace-Tip Electrodes with 510(k) number K071343, and Unimed’s Needle Electrodes with 510(k) number K944265 6. Technological characteristic The proposed Single Use Micro Electro… | 2008 |
| * | K944265 | Needle ElctrodeSummary page 5…urrent during an electrosurgical procedure 5. Predicate device Ellman’s Ace-Tip Electrodes with 510(k) number K071343, and Unimed’s Needle Electrodes with 510(k) number K944265 6. Technological characteristic The proposed Single Use Micro Electrode has equivalent construction and performance as the predi… | 1995 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163442 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163442: Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163442
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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