510(k) · Cleared
ClearedNikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model 4760 (Typically)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paladin Medical, Inc. · HAM Apparatus, Electrosurgical
Cleared on Nov 3, 1999 as substantially equivalent to K853291 (Bio-Detek, Inc., 1985) after a 30-day review. Its family tree reaches back 1 generation to 1985. 3 of the 22 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it.
- Decided
- Nov 3, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- HAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853291 (1985). 20 later devices descend from it, 1 citing it directly. 3 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK853291 GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 1985
- This deviceK993306 Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial…Paladin Medical, Inc. · 1999
- Descendant · cites it directly · 19 of its ownK030362 Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003
- Descendant · 2 generations on · 14 of its ownK063161 Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006
- Descendant · 2 generations on · 4 of its ownK140500 SkintactLeonhard Lang GmbH · 2014
- Descendant · 3 generations on · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK173877 BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K030362Skintact Cool Contact Electrosurgical Grounding PlatesLeonhard Lang GmbH · 2003 · cites it directly19descendants
- K063161Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelLeonhard Lang GmbH · 2006 · 2 generations on14descendants
- K140500SkintactLeonhard Lang GmbH · 2014 · 2 generations on4descendants
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 3 generations on4descendants
- K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300 | Bio-Detek, Inc. | 1985 | — |
| 0 (this device) | 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 | — |
| +2 | K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel | Leonhard Lang GmbH | 2006 | — |
| +2 | K140500 | Skintact | Leonhard Lang GmbH | 2014 | — |
| +3 | K080741 | Mega Soft Reusable Patient Return Electrode | Megadyne Medical Products, Inc. | 2008 | Class I |
| +3 | K173877 | BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 1 |
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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K853291 | GP-100 Adult Electrosurgical Ground Pad/200 & 300Summary page 1…999 TRADE NAME: Nikopad* Electrosurgical Grounding Pad (*or sold under various commercial names) COMMON NAME: Electrosurgical Grounding Pad SUBSTANTIALLY EQUIVALENT TO: K853291: GP-100 Adult Electrosurgical Ground Pad DESCRIPTION of the DEVICE: The Nikopad Electrosurgical Grounding Pad is a flexible, co… | 1985 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030362 | Skintact Cool Contact Electrosurgical Grounding Plates | 2003 | 19 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K030362 (Leonhard Lang GmbH, 2003) has gone furthest, with 19 descendants of its own.
How does its category compare?
All HAM devicesHAM Apparatus, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAM
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HAM
Too few HAM 510(k)s in any year since 2007 to give a median.
Recalls per year · HAM
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAM
2in 2025
MAUDE reports naming product code HAM, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
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/K993306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993306: Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model 4760 (Typically).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993306
Report an extraction error
Are you the manufacturer?
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