510(k) · Cleared
ClearedUltrasonic Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · LFL Instrument, Ultrasonic Surgical
Cleared on Oct 4, 2017 as substantially equivalent to K111202 (Olympus Medical Systems Corp., 2012) after a 28-day review. Its family tree reaches back 8 generations to 1994. 4 later devices descend from it.
- Decided
- Oct 4, 2017
- Review
- 28 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932293 (1994). 63 ancestors in all, the oldest K801623 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 6 generations backK031133 Surgrx Enseal Vessel Sealing and Hemostasis System Including the…Surgrx, Inc. · 2003
- 5 generations backK061526 Enseal PTC Tissue Sealing DeviceSurgrx, Inc. · 2006
- 4 generations backK062949 Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc. · 2006
- 3 generations backK070165 Enseal PTC TrioSurgrx, Inc. · 2007 · Recalled
- 2 generations backK081129 Enseal…Surgrx, Inc. · 2008
- 1 generation backK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- This deviceK172691 Ultrasonic GeneratorOlympus Medical Systems Corp. · 2017
- Descendant · cites it directly · 3 of its ownK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK254056 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)…Olympus Medical Systems Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless…Olympus Medical Systems Corporation · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U…Olympus Winter & Ibe GmbH · 2023 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · cites it directly3descendants
- K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp. · 2026 · 2 generations on0descendants
- K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −7 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −6 | K031133 | Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal… | Surgrx, Inc. | 2003 | — |
| −5 | K061526 | Enseal PTC Tissue Sealing Device | Surgrx, Inc. | 2006 | — |
| −4 | K062949 | Enseal PTC Tissue Seating Sealing Device | Surgrx, Inc. | 2006 | — |
| −3 | K070165 | Enseal PTC Trio | Surgrx, Inc. | 2007 | 1 |
| −2 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| −1 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| 0 (this device) | K172691 | Ultrasonic Generator | Olympus Medical Systems Corp. | 2017 | — |
| +1 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | 13 |
| +2 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT… | Olympus Medical Systems Corp. | 2026 | — |
| +2 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer… | Olympus Medical Systems Corporation | 2025 | 4 |
| +2 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W)… | Olympus Winter & Ibe GmbH | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K111202 | Surgical Tissue Management SystemSummary page 5…Device Name USG-400 Ultrasonic Generator Predicate Devices Olympus Medical Systems Corp. Ultrasonic Generator USG-400 Ver 1 K111202 Device Description The Ultrasonic Generator USG-400 Ver 2 is intended to be used with the Electrosurgical Generator ESG-400, th… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | 2021 | 3 |
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 23 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 8 of the 63 ancestors have a recall of any class.
- Of its descendants, K211838 (Olympus Medical Systems Corporation, 2021) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K111202.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172691: Ultrasonic Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172691
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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