510(k) · Cleared
Recalled · 2009Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 21, 2005 as substantially equivalent to K033003 (Modern Medical Equipment Mfg., Ltd., 2004) after a 79-day review. Its family tree reaches back 1 generation to 2004. 26 later devices descend from it. It has been recalled once.
- Decided
- Oct 21, 2005
- Review
- 79 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033003 (2004). 26 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK033003 Suction CoagulatorModern Medical Equipment Mfg., Ltd. · 2004 · Recalled
- This deviceK052104 Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183…Conmed Corporation · 2005
- Descendant · cites it directly · 25 of its ownK073616 Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
- Descendant · 2 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
- Descendant · 3 generations on · 6 of its ownK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008 · cites it directly25descendants
- K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 2 generations on24descendants
- K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 3 generations on8descendants
- K142410Elliquence ElectrodesElliquence, LLC · 2015 · 3 generations on7descendants
- K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033003 | Suction Coagulator | Modern Medical Equipment Mfg., Ltd. | 2004 | 1 |
| 0 (this device) | K052104 | Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184… | Conmed Corporation | 2005 | — |
| +1 | K073616 | Fas-Clean Electrosurgical Coated Active Blade | Electromedics Co., Ltd. | 2008 | — |
| +2 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| +3 | K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | Peak Surgical, Inc. | 2010 | — |
| +3 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
| +3 | K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K033003 | Suction CoagulatorSummary page 1…n Coagulator (21 CIFR 878.4400) 79 GEL Predicate Device: Suction Coagulator 51 0(k) II K033003 Device Description: This suction coagulator has applications in general surgical procedures to provide a means of coagulation us… | 2004 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073616 | Fas-Clean Electrosurgical Coated Active Blade | 2008 | 25 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2009 | Not classified | Z-0165-2010 | Process control | One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K073616 (Electromedics Co., Ltd., 2008) has gone furthest, with 25 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 | — |
What is it indicated for?
Single-use electrosurgical accessory used to provide coagulation therapeutic energy to tissue and suction to aspirate blood, coagulum and small bits of tissue debris from the surgical site. The coagulation effect is achieved by the passage of high frequency current through the tissue of interest.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052104: Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052104
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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