510(k) · Cleared
ClearedValleylab Suction Coagulator, Model E3305
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien LP · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 11, 2009 as substantially equivalent to K791752 (Valleylab, Inc., 1979) and 1 other predicate after a 137-day review. Its family tree reaches back 2 generations to 1979. 5 later devices descend from it.
- Decided
- Sep 11, 2009
- Review
- 137 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791752 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK791752 Lectrovac, Valleylab ModelsValleylab, Inc. · 1979
- 1 generation backK072559 Suction CoagulatorMegadyne Medical Products, Inc. · 2007 · Recalled
- This deviceK091223 Valleylab Suction Coagulator, Model E3305Covidien LP · 2009
- Descendant · cites it directly · 2 of its ownK121678 DTADGyrus Acmi, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK103775 Peak Suction CoagulatorPeak Surgical, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK150297 PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy · 2015
Most influential descendants
Showing 5 of 5 · See all- K121678DTADGyrus Acmi, Inc. · 2012 · cites it directly2descendants
- K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · 2 generations on1descendant
- K103775Peak Suction CoagulatorPeak Surgical, Inc. · 2011 · cites it directly1descendant
- K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022 · 3 generations on0descendants
- K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791752 | Lectrovac, Valleylab Models | Valleylab, Inc. | 1979 | — |
| −1 | K072559 | Suction Coagulator | Megadyne Medical Products, Inc. | 2007 | 2 |
| 0 (this device) | K091223 | Valleylab Suction Coagulator, Model E3305 | Covidien LP | 2009 | — |
| +1 | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| +2 | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | 12 |
| +1 | K103775 | Peak Suction Coagulator | Peak Surgical, Inc. | 2011 | — |
| +3 | K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022 | — |
| +2 | K150297 | PlasmaBlade UPPP and Suction Coagulator | Medtronic Advanced Energy | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K791752 | Lectrovac, Valleylab ModelsSummary page 1…Predicate Devices The Valleylab Suction Coagulators are substantially equivalent to the following legally marketed medical devices: * Valleylab Lectrovac (K791752) * Megadyne Suction Coagulator (K072559) 4. Device Description The Valleylab Suction Coagulators are hand hel… | 1979 |
| * | K072559 | Suction CoagulatorSummary page 1…lators are substantially equivalent to the following legally marketed medical devices: * Valleylab Lectrovac (K791752) * Megadyne Suction Coagulator (K072559) 4. Device Description The Valleylab Suction Coagulators are hand held electrosurgical devices used for the coagulat… | 2007 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 3 companies; a new generation was cleared every 28.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K121678 (Gyrus Acmi, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K791752.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Suction Coagulator is a single use device intended for use in surgical procedures (such as general and ENT procedures) where the coagulation of tissue and suction of fluids are desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091223: Valleylab Suction Coagulator, Model E3305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091223
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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