510(k) · Cleared
ClearedE7509 Polyhesive II Patient Return Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 6, 1986 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 6, 1986
- Review
- 49 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK861036 E7509 Polyhesive II Patient Return ElectrodeValleylab, Inc. · 1986
- Descendant · cites it directly · 2 of its ownK102372 Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models…Jiangmen City Xinhui Baisheng Medical Equipment CO · 2010
- Descendant · 2 generations on · 1 of its ownK130027 Disposable Neutral Electrode GP202Cathay Manufacturing Corp. · 2013
- Descendant · 3 generations on · 0 of its ownK203293 Abbott Medical Grounding Pad, model RF-DGP-ISAbbott Medical · 2022
- Descendant · cites it directly · 0 of its ownK963307 GDC Patient Return Electtrode Model 45021Target Therapeutics · 1996
Most influential descendants
Showing 4 of 4 · See all- K102372Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DBJiangmen City Xinhui Baisheng Medical Equipment CO · 2010 · cites it directly2descendants
- K130027Disposable Neutral Electrode GP202Cathay Manufacturing Corp. · 2013 · 2 generations on1descendant
- K203293Abbott Medical Grounding Pad, model RF-DGP-ISAbbott Medical · 2022 · 3 generations on0descendants
- K963307GDC Patient Return Electtrode Model 45021Target Therapeutics · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861036 | E7509 Polyhesive II Patient Return Electrode | Valleylab, Inc. | 1986 | — |
| +1 | K102372 | Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DB | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2010 | — |
| +2 | K130027 | Disposable Neutral Electrode GP202 | Cathay Manufacturing Corp. | 2013 | — |
| +3 | K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | Abbott Medical | 2022 | — |
| +1 | K963307 | GDC Patient Return Electtrode Model 45021 | Target Therapeutics | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K102372 (Jiangmen City Xinhui Baisheng Medical Equipment CO, 2010) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K861036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861036: E7509 Polyhesive II Patient Return Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861036
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026