510(k) · Cleared
ClearedDisposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan Quanding Medical Supplies Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 25, 2024 as substantially equivalent to K203494 (Nissha Medical Technologies, Ltd., 2021) after a 61-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- Sep 25, 2024
- Review
- 61 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K853291 (1985). 12 ancestors in all, the oldest K813072 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 6 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 5 generations backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- 4 generations backK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- 3 generations backK140500 SkintactLeonhard Lang GmbH · 2014
- 2 generations backK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
- 1 generation backK203494 Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd. · 2021
- This deviceK242204 Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P…Dongguan Quanding Medical Supplies Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −6 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −5 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| −4 | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| −3 | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| −2 | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
| −1 | K203494 | Nissha Medical Technologies Neutral Electrodes | Nissha Medical Technologies, Ltd. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K203494 | Nissha Medical Technologies Neutral ElectrodesSummary page 6…al & Plastic Surgery ⚫ Product Code: GEI ⚫ Regulation Number: 21 CFR 878.4400 ⚫ Regulation Class: 2 4 Predicate device Information Legally marketed device K203494 Trade Name: Nissha Medical Technologies Neutral Electrodes Classification Name: Electrosurgical cutting and coagulation device… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242204: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242204
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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