510(k) · Cleared
ClearedObs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangmen City Xinhui Baisheng Medical Equipment CO · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 3, 2010 as substantially equivalent to K030362 (Leonhard Lang GmbH, 2003) and 2 other predicates after a 75-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.
- Decided
- Nov 3, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K853291 (1985). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 2 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 1 generation backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- This deviceK102372 Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models…Jiangmen City Xinhui Baisheng Medical Equipment CO · 2010
- Descendant · cites it directly · 1 of its ownK130027 Disposable Neutral Electrode GP202Cathay Manufacturing Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK203293 Abbott Medical Grounding Pad, model RF-DGP-ISAbbott Medical · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −2 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −1 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| 0 (this device) | K102372 | Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DB | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2010 | — |
| +1 | K130027 | Disposable Neutral Electrode GP202 | Cathay Manufacturing Corp. | 2013 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K030362 | Skintact Cool Contact Electrosurgical Grounding PlatesSummary page 1…inbH Address: Archenweg 56 6010 Innsbruck Austria Proprietary Name: Skintact® Cool Contact Electrosurgical Grounding Plates It's 510(K) number is K030362 Code: FDA-005 IVersion: NO0 Page 1 of 4 Issuing Date: 2009-12-28… | 2003 |
| * | K002002 | Surefit Dispersive ElectrodeSummary page 2…: ConMed Corporation Address: 310 Broad Street Utica, New York 13501 Proprietary Name: SureFiP' Dual Dispersive Electrode (410-2000) It's 510(K) number is K002002 3) Valleylab Company Name: Valleylab,INC. Address: 5910 Longbow Drive Boulder CO 80301 Proprietary Name: PolyHes… | 2000 |
| * | K861036 | E7509 Polyhesive II Patient Return ElectrodeSummary page 2…ectrode(Mode E7506:solid,with cable.Model E7507:REM,with cable. Model E7509: REM,without cable) It's 510(K) number is K861036 4.0 Device Description OBS Disposable Electrosurgical Pads are disposable, non-sterile dispersive electrode with or without… | 1986 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130027 | Disposable Neutral Electrode GP202 | 2013 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K130027 (Cathay Manufacturing Corp., 2013) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K030362.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
OHS Disposable Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They 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 as stated in the FDA summary.
https://510kreport.com/device/K102372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102372: Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102372
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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