510(k) · Cleared
ClearedNissha Medical Technologies Neutral Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nissha Medical Technologies, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 23, 2021 as substantially equivalent to K173877 (Bowa-Electronics GmbH & Co. KG, 2018) after an 88-day review. Its family tree reaches back 6 generations to 1985. 1 later device descends from it.
- Decided
- Feb 23, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K853291 (1985). 11 ancestors in all, the oldest K813072 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 5 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 4 generations backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- 3 generations backK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- 2 generations backK140500 SkintactLeonhard Lang GmbH · 2014
- 1 generation backK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
- This deviceK203494 Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK242204 Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P…Dongguan Quanding Medical Supplies Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242204Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A…Dongguan Quanding Medical Supplies Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −5 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −4 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| −3 | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| −2 | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| −1 | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
| 0 (this device) | K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | 2021 | — |
| +1 | K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I… | Dongguan Quanding Medical Supplies 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 |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K173877 | BOWA Neutral ElectrodesSummary page 4…GmbH & Co. KG BOWA Neutral Trade Name Electrodes K173877 510(k) Number Primary predicate 5) Indication for Use Statement Nissha Medical Techno… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242204 | Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A… | 2024 | 0 |
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 36 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K242204 (Dongguan Quanding Medical Supplies Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173877.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient’s skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These…
Read the full statement (163 words)
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient’s skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur.
Nissha Medical Technologies Neutral Electrodes – Boston Scientific:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient’s skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices “Boston Scientific G4™ and 1A/1B Radiofrequency Generators”.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203494: Nissha Medical Technologies 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/K203494
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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