510(k) · Cleared
ClearedBOWA Neutral Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bowa-Electronics GmbH & Co. KG · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 15, 2018 as substantially equivalent to K063161 (Leonhard Lang GmbH, 2006) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1985. 3 later devices descend from it.
- Decided
- Feb 15, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K853291 (1985). 10 ancestors in all, the oldest K813072 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 4 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 3 generations backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- 2 generations backK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- 1 generation backK140500 SkintactLeonhard Lang GmbH · 2014
- This deviceK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
- Descendant · cites it directly · 1 of its ownK203494 Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK242204 Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P…Dongguan Quanding Medical Supplies Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK231985 Disposable Grounding PadShenzhen Mecun Medical Supply Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K203494Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021 · cites it directly1descendant
- K242204Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A…Dongguan Quanding Medical Supplies Co., Ltd. · 2024 · 2 generations on0descendants
- K231985Disposable Grounding PadShenzhen Mecun Medical Supply Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −4 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −3 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| −2 | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| −1 | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| 0 (this device) | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
| +1 | K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | 2021 | — |
| +2 | K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I… | Dongguan Quanding Medical Supplies Co., Ltd. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 5…kintact® Neutral Electrodes for Electrosurgical Grounding Neonates Plates with NH 04 Gel 510(k) Number K063161 K140500 Primary predicate Secondary predicate 6. Indi… | 2006 |
| * | K140500 | SkintactSummary page 5…Electrosurgical Grounding Neonates Plates with NH 04 Gel 510(k) Number K063161 K140500 Primary predicate Secondary predicate 6. Indication for Use Statement Disposabl… | 2014 |
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 33 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K203494 (Nissha Medical Technologies, Ltd., 2021) 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. 2018, 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?
Disposable neutral electrodes are self-adhesive, ready-to-use and single-use products and are an accessory for HF surgery in monopolar applications. The electrodes complete the electrical circuit between the patient and the HF generator on the passive side.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173877: BOWA Neutral Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173877
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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