510(k) · Cleared
ClearedOlympus Sonosurg Trocar XT3900 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · LFL Instrument, Ultrasonic Surgical
Cleared on Sep 26, 2000 after a 257-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.
- Decided
- Sep 26, 2000
- Review
- 257 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 6 citing it directly.
- This deviceK000095 Olympus Sonosurg Trocar XT3900 SystemThe Olympus Optical Co. · 2000
- Descendant · cites it directly · 26 of its ownK031305 Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 19 of its ownK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
- Descendant · 2 generations on · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · cites it directly · 18 of its ownK031523 Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
- Descendant · cites it directly · 18 of its ownK031710 Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K031305Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd. · 2003 · cites it directly26descendants
- K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003 · cites it directly19descendants
- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · 2 generations on18descendants
- K031523Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003 · cites it directly18descendants
- K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000095 | Olympus Sonosurg Trocar XT3900 System | The Olympus Optical Co. | 2000 | — |
| +1 | K031305 | Olympus Ultrasonic Surgical System | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K021962 | Olympus Ultrasonic Surgical System | The Olympus Optical Co. | 2003 | — |
| +2 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +1 | K031523 | Olympus Ultrasonic Surgical System | Aomori Olympus Co., Ltd. | 2003 | — |
| +1 | K031710 | Olympus Ultrasonic Surgical System | Aomori Olympus Co., Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (35)
See all 356 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?
- Of its descendants, K031305 (Olympus Optical Co., Ltd., 2003) has gone furthest, with 26 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
https://510kreport.com/device/K000095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000095: Olympus Sonosurg Trocar XT3900 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000095
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026