510(k) · Cleared
Recalled · Class II · 2023Suction Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 5, 2007 as substantially equivalent to K791752 (Valleylab, Inc., 1979) after a 24-day review. Its family tree reaches back 1 generation to 1979. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 5, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791752 (1979). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK791752 Lectrovac, Valleylab ModelsValleylab, Inc. · 1979
- This deviceK072559 Suction CoagulatorMegadyne Medical Products, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK091223 Valleylab Suction Coagulator, Model E3305Covidien LP · 2009
- Descendant · 2 generations on · 2 of its ownK121678 DTADGyrus Acmi, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK103775 Peak Suction CoagulatorPeak Surgical, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091223Valleylab Suction Coagulator, Model E3305Covidien LP · 2009 · cites it directly5descendants
- K121678DTADGyrus Acmi, Inc. · 2012 · 2 generations on2descendants
- K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · 3 generations on1descendant
- K103775Peak Suction CoagulatorPeak Surgical, Inc. · 2011 · 2 generations on1descendant
- K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791752 | Lectrovac, Valleylab Models | Valleylab, Inc. | 1979 | — |
| 0 (this device) | K072559 | Suction Coagulator | Megadyne Medical Products, Inc. | 2007 | — |
| +1 | K091223 | Valleylab Suction Coagulator, Model E3305 | Covidien LP | 2009 | — |
| +2 | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| +3 | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | 12 |
| +2 | K103775 | Peak Suction Coagulator | Peak Surgical, Inc. | 2011 | — |
| +4 | K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K946327 | MegaDyne Suction Coagulator Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…oagulation device and accessories E. PredicateDevices The predicate devices include the MegaDyne Suction Coagulator which was cleared for marketing via 510(k) # K946327 by FDA's Office of Device Evaluation on June- 7, 1995; and Valleylab's Lectrovac which was cleared for marketing via 510(k)… | |
| * | K791752 | Lectrovac, Valleylab ModelsSummary page 2…for marketing via 510(k) # K946327 by FDA's Office of Device Evaluation on June- 7, 1995; and Valleylab's Lectrovac which was cleared for marketing via 510(k) #K791752 on October 4, 1979. F. Applicant Device Description The suction coagulator is a hand held electrosurgical device used for c… | 1979 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091223 | Valleylab Suction Coagulator, Model E3305 | 2009 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2023 | Class II | Z-2257-2023 | Under Investigation by firm | An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU). |
| Feb 27, 2014 | Class II | Z-1151-2014 | Use error | Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072559 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072559: Suction Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072559
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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