510(k) · Cleared
ClearedOlympus Ultrasonic Surgical System Sonosurg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · LFL Instrument, Ultrasonic Surgical
Cleared on Jun 3, 2005 as substantially equivalent to K021962 (The Olympus Optical Co., 2003) and 3 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1980. 15 later devices descend from it.
- Decided
- Jun 3, 2005
- Review
- 57 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K801623 (1980). 25 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 3 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 2 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 1 generation backK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
- This deviceK050885 Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005
- Descendant · cites it directly · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
- Descendant · 3 generations on · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- Descendant · 4 generations on · 4 of its ownK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 4 of its ownK172610 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5…Olympus Medical Systems Corp. · 2018 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · cites it directly11descendants
- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 2 generations on9descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · 3 generations on6descendants
- K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020 · 4 generations on4descendants
- K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp. · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −3 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −2 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −1 | K021962 | Olympus Ultrasonic Surgical System | The Olympus Optical Co. | 2003 | — |
| 0 (this device) | K050885 | Olympus Ultrasonic Surgical System Sonosurg | Olympus Medical Systems Corporation | 2005 | — |
| +1 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| +2 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
| +3 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| +4 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm… | Olympus Medical Systems Corp. | 2018 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K021962 | Olympus Ultrasonic Surgical SystemSummary page 2…Product Device Name 510(k) # Manufacturer Class Code Olympus Ultrasonic Surgical #K021962 Olympus Corporation n System #K031523 #K03171… | 2003 |
| * | K031523 | Olympus Ultrasonic Surgical SystemSummary page 2…Manufacturer Class Code Olympus Ultrasonic Surgical #K021962 Olympus Corporation n System #K031523 #K031710 Olympus SonoSurg System #K972114 Olympus Corporation.… | 2003 |
| * | K031710 | Olympus Ultrasonic Surgical SystemSummary page 2…Olympus Ultrasonic Surgical #K021962 Olympus Corporation n System #K031523 #K031710 Olympus SonoSurg System #K972114 Olympus Corporation. LFL D. SUMMARY DESCRIPTION OF THE D… | 2003 |
| * | K972114 | Olympus Sonosurg SystemSummary page 2…Olympus Corporation n System #K031523 #K031710 Olympus SonoSurg System #K972114 Olympus Corporation. LFL D. SUMMARY DESCRIPTION OF THE DEVICE 1. Summary The major components… | 1998 |
What descends from it? (15)
See all 152 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 25 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K111202 (Olympus Medical Systems Corp., 2012) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K021962.
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 | — |
What is it indicated for?
These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050885: Olympus Ultrasonic Surgical System Sonosurg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050885
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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