510(k) Report

510(k) · Cleared

Cleared

Sonosurg System

K032066510(k) TraditionalCleared Oct 3, 200392-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Olympus Optical Co. · LFL Instrument, Ultrasonic Surgical

Cleared on Oct 3, 2003 as substantially equivalent to K021962 (The Olympus Optical Co., 2003) and 3 other predicates after a 92-day review. Its family tree reaches back 4 generations to 1980. 1 later device descends from it.

Decided
Oct 3, 2003
Review
92 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K801623 (1980). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1998: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors1992: 1 other ancestor1991: 2 other ancestors1988: 2 other ancestors1993: 1 other ancestor2004: 1 descendant clearedK801623 · Cavitron Ultrasonic Surg. Aspir. Cusa · Cavitron Corp. · 1980K962952 · Olympus Ultrasonic Surgical System (Usu) · Olympus Optical, Co. · 1996K972114 · Olympus Sonosurg System · The Olympus Optical Co. · 1998K021962 · Olympus Ultrasonic Surgical System · The Olympus Optical Co. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant K021962 · Olympus Ultrasonic Surgical System · The Olympus Optical Co. · 2003K972114 · Olympus Sonosurg System · The Olympus Optical Co. · 1998K962952 · Olympus Ultrasonic Surgical System (Usu) · Olympus Optical, Co. · 1996K801623 · Cavitron Ultrasonic Surg. Aspir. Cusa · Cavitron Corp. · 19800
  1. Root · 4 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
  2. 3 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
  3. 2 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
  4. 1 generation backK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
  5. This deviceK032066 Sonosurg SystemThe Olympus Optical Co. · 2003
  6. Descendant · cites it directly · 0 of its ownK041566 Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K801623Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp.1980—
−3K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co.1996—
−2K972114Olympus Sonosurg SystemThe Olympus Optical Co.1998—
−1K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co.2003—
0 (this device)K032066Sonosurg SystemThe Olympus Optical Co.2003—
+1K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198820
199120
199210
199310
199420
199530
199810
199910
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K032066, 1980–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K021962Olympus Ultrasonic Surgical System
Summary page 2
…el UES-20 or UES-30 Electrosurgical Units. 5. Summary including conclusion drawn from Non-clinical Tests When compared to the Olympus Ultrasonic Surgical Systern(#K021962), CUSA Excel Ultrasonic Surgical Aspirator System(#K981262), SONOPET UST-2001 Ultra Surgical Aspirator(#KO10309) and Ultras…
The Olympus Optical Co.2003—
*K981262Cusa Excel Ultrasonic Surgical Aspirator System
Summary page 2
…uding conclusion drawn from Non-clinical Tests When compared to the Olympus Ultrasonic Surgical Systern(#K021962), CUSA Excel Ultrasonic Surgical Aspirator System(#K981262), SONOPET UST-2001 Ultra Surgical Aspirator(#KO10309) and Ultrasonic Surgical System(#K962952), the Olyrnpus Surgical System…
Valleylab, Inc.19983
*K010309Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorMutoh America Co., Ltd.20014
*K962952Olympus Ultrasonic Surgical System (Usu)
Summary page 2
…l Systern(#K021962), CUSA Excel Ultrasonic Surgical Aspirator System(#K981262), SONOPET UST-2001 Ultra Surgical Aspirator(#KO10309) and Ultrasonic Surgical System(#K962952), the Olyrnpus Surgical System does not incorporate any significant changes in the intended use, method of operation, material…
Olympus Optical, Co.1996—

Also cleared against K021962: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040

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.
  • 2 of the 20 ancestors have a recall of any class.
  • Of its descendants, K041566 (Aomori Olympus Co., Ltd., 2004) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K021962.

How does its category compare?

All LFL devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFL

3in 2025

2007: 72008: 22009: 12010: 22011: 32012: 32013: 52014: 32015: 42016: 52017: 22018: 32019: 42020: 42021: 62022: 82023: 42024: 32025: 32026 (partial year): 3
2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007: 99 days median2011: 241 days median2012: 82 days median2013: 73 days median2014: 136 days median2015: 99 days median2016: 111 days median2018: 66 days median2019: 103 days median2020: 190 days median2021: 83 days median2022: 168 days median2023: 104 days median2024: 158 days median2025: 176 days median2026 (partial year): 99 days median
2007high 241 (2011) · low 66 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFL

11in 2024

2010: 32011: 22012: 52014: 12015: 12017: 12019: 422021: 12023: 22024: 112026 (partial year): 1
2007high 42 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFL

3,857in 2025

2007: 2,2362008: 1,6782009: 3,3242010: 1,2392011: 1,0532012: 1,4912013: 2,4302014: 4,2602015: 2,7772016: 2,6912017: 3,2672018: 3,4612019: 3,1532020: 2,9342021: 3,2892022: 3,4222023: 4,2152024: 4,0172025: 3,857
2007high 4,260 (2014) · low 1,053 (2011)2025

MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200779902,236
20082—01,678
20091—03,324
20102—31,239
2011324121,053
201238251,491
201357302,430
2014313614,260
201549912,777
2016511102,691
20172—13,267
201836603,461
20194103423,153
2020419002,934
202168313,289
2022816803,422
2023410424,215
20243158114,017
2025317603,857
20263991—

What is it indicated for?

The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-72L-GE. SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T.3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

Indications for use as stated in the FDA summary.

Also cleared against K021962

4 other devices cite the same predicate.

  • K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 201210 recalls
  • K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005
  • K042160Sonosurg TrocarAomori Olympus Co., Ltd. · 2005
  • K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2004

More from The Olympus Optical Co.

22 FDA decisions under this applicant name. See the company

  • K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 20033 recalls
  • K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
  • K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 200314 Class I recalls
  • K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 20021 recall
  • K023767Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002

Recent decisions in LFL

The LFL category page

  • K261361TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque…Carl Zeiss Meditec, AG · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
  • K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2025
  • K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced…Shanghai Saints Sages Surgical Co., Ltd. · 2025

https://510kreport.com/device/K032066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032066: Sonosurg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032066

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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