510(k) · Cleared
ClearedSkintact
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 Jul 29, 2014 as substantially equivalent to K063161 (Leonhard Lang GmbH, 2006) and 2 other predicates after a 152-day review. Its family tree reaches back 4 generations to 1985. 4 later devices descend from it.
- Decided
- Jul 29, 2014
- Review
- 152 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K853291 (1985). 9 ancestors in all, the oldest K813072 (1981). 4 later devices descend from it, 1 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 deviceK140500 SkintactLeonhard Lang GmbH · 2014
- Descendant · cites it directly · 3 of its ownK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
- Descendant · 2 generations on · 1 of its ownK203494 Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK242204 Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P…Dongguan Quanding Medical Supplies Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK231985 Disposable Grounding PadShenzhen Mecun Medical Supply Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018 · cites it directly3descendants
- K203494Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021 · 2 generations on1descendant
- K242204Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A…Dongguan Quanding Medical Supplies Co., Ltd. · 2024 · 3 generations on0descendants
- K231985Disposable Grounding PadShenzhen Mecun Medical Supply Co., Ltd. · 2024 · 2 generations on0descendants
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) | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| +1 | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
| +2 | K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | 2021 | — |
| +3 | K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I… | Dongguan Quanding Medical Supplies Co., Ltd. | 2024 | — |
| +2 | K231985 | Disposable Grounding Pad | Shenzhen Mecun Medical Supply Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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? (3)
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…cessories PRO CODE. GEl Regulation No.: 21CFR 878.4400 Classification: Class 11 SUBSTANTIALLY EQUIVALENT TO: K063161 Leonhard Lang Skintact" Cool Contact Electrosurgical Grounding Plates, Leonhardi Lang… | 2006 |
| * | K030362 | Skintact Cool Contact Electrosurgical Grounding PlatesSummary page 1…Skintact" Cool Contact Electrosurgical Grounding Plates, Leonhardi Lang GmbH with NHO14 Gel, decision date: 11/21/2006 K030362 Leonhard Lang Skintact® Cool Contact Electrosurgical Grounding Plates, Leonhard Lang G… | 2003 |
| * | K994428 | E7512 Premie Rem Polyhesive II Patient Return ElectrodeSummary page 1…Leonhard Lang Skintact® Cool Contact Electrosurgical Grounding Plates, Leonhard Lang GmbH, decision date: 04/14/2003 K994428 E7512 Premie REM PolyHesive 11Patient Return Electrode, Valleylab Inc., decision date:… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173877 | BOWA Neutral Electrodes | 2018 | 3 |
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 29 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K173877 (Bowa-Electronics GmbH & Co. KG, 2018) has gone furthest, with 3 descendants 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. 2014, 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?
Skintat Neutral Electrodes for Neonates are designed for use with electrosurgical
generators for culling and coagulation of human tissue of newborn or prematurely
born patients of between approximately I and 11 lbs (0.45 kg and 4.99 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140500: Skintact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140500
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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