510(k) · Cleared
ClearedDisposable Grounding Pad Series and Electrode Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shuyou Electric Medical Science Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 4, 2009 as substantially equivalent to K063161 (Leonhard Lang GmbH, 2006) and 1 other predicate after a 178-day review. Its family tree reaches back 4 generations to 1985. 3 later devices descend from it.
- Decided
- Dec 4, 2009
- Review
- 178 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K853291 (1985). 11 ancestors in all, the oldest K780977 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 3 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 2 generations backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- 1 generation backK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- This deviceK091672 Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK152059 Disposable General ElectrodeModern Medical Equipment Manufacturing Limited · 2016
- Descendant · 2 generations on · 0 of its ownK171707 GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B…Gowoonsesang Cosmetics Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK160366 Electrosurgical disposable grounding padsTop-Rank Health Care Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K152059Disposable General ElectrodeModern Medical Equipment Manufacturing Limited · 2016 · cites it directly1descendant
- K171707GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1AGowoonsesang Cosmetics Co., Ltd. · 2017 · 2 generations on0descendants
- K160366Electrosurgical disposable grounding padsTop-Rank Health Care Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −3 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −2 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| −1 | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| 0 (this device) | K091672 | Disposable Grounding Pad Series and Electrode Series | Shuyou Electric Medical Science Co., Ltd. | 2009 | — |
| +1 | K152059 | Disposable General Electrode | Modern Medical Equipment Manufacturing Limited | 2016 | — |
| +2 | K171707 | GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A | Gowoonsesang Cosmetics Co., Ltd. | 2017 | — |
| +1 | K160366 | Electrosurgical disposable grounding pads | Top-Rank Health Care Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelSummary page 1…ion Purpose: New Device Predicate Device: Skintact Cool Contact Electrosurgical Grounding Plates (K(063161) E-Z Clean electrosurgical electrodes (K08 1791) Test Conclusion The Di… | 2006 |
| * | K081791 | E-Z Clean Electrosurgical ElectrodeSummary page 1…ct Cool Contact Electrosurgical Grounding Plates (K(063161) E-Z Clean electrosurgical electrodes (K08 1791) Test Conclusion The Disposable Grounding Pad and Disposable Electrode are… | 2008 |
What descends from it? (3)
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K152059 (Modern Medical Equipment Manufacturing Limited, 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K063161.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Disposable Grounding Pad series devices are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
The Disposable Electrode series devices are intended to conduct radio frequency (RE) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091672: Disposable Grounding Pad Series and Electrode Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091672
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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