510(k) · Cleared
ClearedAdaptable Monopolar Electrodes with Ceramic Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 13, 2005 as substantially equivalent to K033249 (Pajunk GmbH, 2004) and 1 other predicate after an 18-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Dec 13, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935270 (1994). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 1 generation backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- This deviceK053282 Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005
- Descendant · cites it directly · 2 of its ownK062047 Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006
- Descendant · 2 generations on · 0 of its ownK190168 Aquas ProbesGenicon, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK073498 Laparoscopic and Electrosurgical Instruments and Accessories…Rudolf Medical GmbH + Co. KG · 2008
Most influential descendants
Showing 3 of 3 · See all- K062047Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006 · cites it directly2descendants
- K190168Aquas ProbesGenicon, Inc. · 2019 · 2 generations on0descendants
- K073498Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf SystemRudolf Medical GmbH + Co. KG · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −1 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| 0 (this device) | K053282 | Adaptable Monopolar Electrodes with Ceramic Tip | Pajunk GmbH | 2005 | — |
| +1 | K062047 | Adaptable Monopolar Adaptable and/or Retractable Electrodes | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +2 | K190168 | Aquas Probes | Genicon, Inc. | 2019 | — |
| +2 | K073498 | Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy… | Rudolf Medical GmbH + Co. KG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K033249 | Pajunk Modular Handle InstrumentsSummary page 1…April 1.~2005 Poposed Classification: Regulatory Class: 1I Proposed Product Code: GEl Predicate Devices: 1. Pajunk's monopolar electrodes marketed under K033249 2. Aesculap's modular monopolar ceramic tip electrodes K970541… | 2004 |
| * | K970541 | Aesculap Modular Monopolar ElectrodesSummary page 1…nk's monopolar electrodes marketed under K033249 2. Aesculap's modular monopolar ceramic tip electrodes K970541 USSpeciaIPMN-510(k)-Ceramnic Tip.doc PMN cQ 2005-11 020 === Page… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062047 | Adaptable Monopolar Adaptable and/or Retractable Electrodes | 2006 | 2 |
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 11 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062047 (PAJUNK GmbH Medizintechnologie, 2006) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K033249.
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 | — |
What is it indicated for?
Ceramic tip electrodes are used during minimal invasive surgery, according to the professional surgeon and the instructions for use.
Ceramic tip electrodes are instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053282: Adaptable Monopolar Electrodes with Ceramic Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053282
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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