510(k) · Cleared
ClearedElectrosurgical disposable grounding pads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top-Rank Health Care Co., Ltd. · ODR Electrosurgical Patient Return Electrode
Cleared on Aug 19, 2016 as substantially equivalent to K091672 (Shuyou Electric Medical Science Co., Ltd., 2009) after a 192-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Aug 19, 2016
- Review
- 192 days
- Class
- Class II
- Product code
- ODR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K853291 (1985). 12 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 5 generations backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- 4 generations backK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- 3 generations backK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- 2 generations backK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- 1 generation backK091672 Disposable Grounding Pad Series and Electrode SeriesShuyou Electric Medical Science Co., Ltd. · 2009
- This deviceK160366 Electrosurgical disposable grounding padsTop-Rank Health Care Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| −4 | K993306 | Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model… | Paladin Medical, Inc. | 1999 | — |
| −3 | K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | Leonhard Lang GmbH | 2003 | — |
| −2 | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| −1 | K091672 | Disposable Grounding Pad Series and Electrode Series | Shuyou Electric Medical Science Co., Ltd. | 2009 | — |
| 0 (this device) | K160366 | Electrosurgical disposable grounding pads | Top-Rank Health Care Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2008 | 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 ODR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091672 | Disposable Grounding Pad Series and Electrode SeriesSummary page 5…ons and not required to be sterilized by the end user prior to operation. However, they are for single use only. 5. Identification of Predicate Device(s) K091672 SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD. Disposable Grounding Pad Series 6. Non-Clinical Test Conclusion No… | 2009 |
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 31 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K091672.
How does its category compare?
All ODR devicesODR Electrosurgical Patient Return Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ODR
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · ODR
Too few ODR 510(k)s in any year since 2007 to give a median.
Recalls per year · ODR
No recall names ODR since 2007.
Adverse event reports per year · ODR
1in 2017
MAUDE reports naming product code ODR, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 94 |
| 2009 | 0 | — | 0 | 118 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160366: Electrosurgical disposable grounding pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160366
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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