510(k) · Cleared
ClearedSkintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leonhard Lang GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 21, 2006 as substantially equivalent to K030362 (Leonhard Lang GmbH, 2003) after a 35-day review. Its family tree reaches back 3 generations to 1985. 3 of the 19 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K853291 (1985). 4 ancestors in all. 14 later devices descend from it, 4 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 2 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 1 generation backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- This deviceK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- Descendant · cites it directly · 4 of its ownK140500 SkintactLeonhard Lang GmbH · 2014
- Descendant · cites it directly · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
- Descendant · 2 generations on · 3 of its ownK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK091672 Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd. · 2009
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K140500SkintactLeonhard Lang GmbH · 2014 · cites it directly4descendants
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · cites it directly4descendants
- K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018 · cites it directly3descendants
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 2 generations on3descendants
- K091672Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd. · 2009 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −2 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −1 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| 0 (this device) | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| +1 | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| +1 | K080741 | Mega Soft Reusable Patient Return Electrode | Megadyne Medical Products, Inc. | 2008 | Class I |
| +1 | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
| +2 | K133726 | Mega Soft Universal Patient Return Electrode | Megadyne Medical Products, Inc. | 2014 | Class I |
| +1 | K091672 | Disposable Grounding Pad Series and Electrode Series | Shuyou Electric Medical Science Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 2014 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 1 |
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.
3 devices in this family have a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K030362 | Skintact Cool Contact Electrosurgical Grounding PlatesSummary page 1…equivalent to the materials of construction used in the Skintact® Cool Contact Electrosurgical Grounding Plates (the manufacturer's predicate device) cleared via 510(k) [K030362]. The Skintact® Cool Contact Electrosurgical Grounding Plates with new NH 04 gel include also a range of electrodes with differen… | 2003 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140500 (Leonhard Lang GmbH, 2014) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K030362.
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?
Skintact Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063161: Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063161
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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