510(k) · Cleared
Recalled · Class II · 2022Suction Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Medical Equipment Mfg., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 13, 2004 after a 231-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it. It has been recalled once.
- Decided
- May 13, 2004
- Review
- 231 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK033003 Suction CoagulatorModern Medical Equipment Mfg., Ltd. · 2004
- Descendant · cites it directly · 26 of its ownK052104 Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183…Conmed Corporation · 2005 · Recalled
- Descendant · 2 generations on · 25 of its ownK073616 Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
- Descendant · 3 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- Descendant · 4 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K052104Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185…Conmed Corporation · 2005 · cites it directly26descendants
- K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008 · 2 generations on25descendants
- K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 3 generations on24descendants
- K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 4 generations on8descendants
- K142410Elliquence ElectrodesElliquence, LLC · 2015 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033003 | Suction Coagulator | Modern Medical Equipment Mfg., Ltd. | 2004 | — |
| +1 | K052104 | Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184… | Conmed Corporation | 2005 | 1 |
| +2 | K073616 | Fas-Clean Electrosurgical Coated Active Blade | Electromedics Co., Ltd. | 2008 | — |
| +3 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| +4 | K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | Peak Surgical, Inc. | 2010 | — |
| +4 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052104 | Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185… | 2005 | 26 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2022 | Class II | Z-0474-2023 | Process control | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052104 (Conmed Corporation, 2005) has gone furthest, with 26 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?
Suction coagulator is used for coagulating tissue and removing fluid and debris from surgical site. Suction and coagulation can be performed independently or simultaneously.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033003: Suction Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033003
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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