510(k) · Cleared
ClearedDisposable Neutral Electrode GP202
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathay Manufacturing Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 22, 2013 as substantially equivalent to K102372 (Jiangmen City Xinhui Baisheng Medical Equipment CO, 2010) after a 231-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Aug 22, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853291 (1985). 7 ancestors in all. 1 later device descends 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 backK102372 Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models…Jiangmen City Xinhui Baisheng Medical Equipment CO · 2010
- This deviceK130027 Disposable Neutral Electrode GP202Cathay Manufacturing Corp. · 2013
- Descendant · cites it directly · 0 of its ownK203293 Abbott Medical Grounding Pad, model RF-DGP-ISAbbott Medical · 2022
Most influential descendants
Showing 1 of 1 · See all- K203293Abbott Medical Grounding Pad, model RF-DGP-ISAbbott Medical · 2022 · cites it directly0descendants
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 | K102372 | Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DB | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2010 | — |
| 0 (this device) | K130027 | Disposable Neutral Electrode GP202 | Cathay Manufacturing Corp. | 2013 | — |
| +1 | K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | Abbott Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K102372 | Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DBSummary page 1…accessories Product Code GEl Submission Type 510(k) Regulation Number 21 CFR 878.4400 Device Class 2 2. Predicate Devices Ki102372 Trade/Device Name: OBS Disposable Electrosurgical Pads Models: GBS-Db, CBS-Din Regulation Number: 21 CFR 878.4400 Regulation Name… | 2010 |
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 |
|---|---|---|---|
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | 2022 | 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 28 years and passes through 5 companies; a new generation was cleared every 7.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K203293 (Abbott Medical, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130027: Disposable Neutral Electrode GP202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130027
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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