510(k) · Cleared
ClearedCardiovations Optical Bipolar Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 21, 2003 after a 35-day review. The FDA summary names its predicate without a number. 2 of the 47 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it.
- Decided
- Jul 21, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 1 citing it directly. 2 of the 47 devices in this family, counting this one, have a Class I recall.
- This deviceK031846 Cardiovations Optical Bipolar DeviceETHICON, Inc. · 2003
- Descendant · cites it directly · 45 of its ownK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- Descendant · 2 generations on · 44 of its ownK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- Descendant · 3 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
- Descendant · 3 generations on · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 46 · See all- K06072340 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006 · cites it directly45descendants
- K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · 2 generations on44descendants
- K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 3 generations on35descendants
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 3 generations on32descendants
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031846 | Cardiovations Optical Bipolar Device | ETHICON, Inc. | 2003 | — |
| +1 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| +2 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| +3 | K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator… | Surgiquest, Inc. | 2011 | — |
| +3 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| +4 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 4 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | Clearglide Precision Bipolar Device Named without a submission number |
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060723 | 40 L High Flow Insufflator F113 | 2006 | 45 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K060723 (W.O.M. World of Medicine AG, 2006) has gone furthest, with 45 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?
The CardioVations Optical Bipolar Device is indicated fat endoscopic and open dissection, bipolar coagulation, and transection of vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031846: Cardiovations Optical Bipolar Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031846
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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