510(k) · Cleared
ClearedOlympus Ultrasonic Surgical 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 Feb 12, 2003 as substantially equivalent to K002981 (Ethicon Endo-Surgery, Inc., 2001) and 3 other predicates after a 243-day review. Its family tree reaches back 3 generations to 1980. 19 later devices descend from it.
- Decided
- Feb 12, 2003
- Review
- 243 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K801623 (1980). 14 ancestors in all. 19 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 2 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 1 generation backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- This deviceK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
- Descendant · cites it directly · 15 of its ownK050885 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005 · cites it directly15descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −2 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −1 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K021962 | Olympus Ultrasonic Surgical System | The Olympus Optical Co. | 2003 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K002981 | Ultracision Harmonic Scalpel Coagulating Shears, Model… | 2001 |
| * | K972114 | Olympus Sonosurg SystemSummary page 1…urgical System 3. Classification Name : Class I1 Instrument, Ultrasonic Surgical LFL C. Predicate Devices : #KO0298 1 Harmonic Scalpel #K972 114 Olympus SonoSurg Scissors Set T3000 #K990430 Hand piece #K972114 Olympus Transducer MAJ-336 #KO00095 SonoSur… | 1998 |
| * | K990430 | Ultracision Harmonic Scalpel Hand PieceSummary page 1…Class I1 Instrument, Ultrasonic Surgical LFL C. Predicate Devices : #KO0298 1 Harmonic Scalpel #K972 114 Olympus SonoSurg Scissors Set T3000 #K990430 Hand piece #K972114 Olympus Transducer MAJ-336 #KO00095 SonoSurg Generator Set SonoSurg-G2 Set D. S… | 1999 |
| * | K000095 | Olympus Sonosurg Trocar XT3900 SystemSummary page 2…s the same as the Predicate Devices which include, “Olympus SonoSurg Scissors Set T3000(#K972114)”, “Olympus Transducer MAJ-336 (#K972 1 14)” and “Olympus SonSurg-G2 (#K000095)”. G. Reason for not requiring clinical data When compared to the predicate devices, “Olympus Ultrasonic Surgical System” does… | 2000 |
What descends from it? (19)
See all 195 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 23 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K050885 (Olympus Medical Systems Corporation, 2005) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K002981.
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?
OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021962 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021962: Olympus Ultrasonic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021962
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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