510(k) · Cleared

Cleared

Olympus Ultrasonic Surgical System (Usu)

K962952510(k) TraditionalCleared Nov 29, 1996122-day reviewClass U

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

Olympus Optical, Co. · LBK Neurosurgical Ultrasonic Instruments

Cleared on Nov 29, 1996 as substantially equivalent to K801623 (Cavitron Corp., 1980) and 4 other predicates after a 122-day review. Its family tree reaches back 1 generation to 1980. 4 of the 220 devices in its family, counting itself, have a Class I recall. 214 later devices descend from it.

Decided: Nov 29, 1996
Review: 122 days
Class: Class U
Product code: LBK
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K801623 (1980). 5 ancestors in all. 214 later devices descend from it, 3 citing it directly. 4 of the 220 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
This deviceK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
Descendant · cites it directly · 213 of its ownK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
Descendant · 2 generations on · 175 of its ownK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
Descendant · 3 generations on · 157 of its ownK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
Descendant · 4 generations on · 154 of its ownK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
Descendant · 5 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled

Showing 5 of 214 descendants. See all descendants

Descendants cleared per year

1998high 17 (2016) · low 0 (1999)2026

Class I recalls in this family

K162859 Allura Xper FD series and Allura Xper OR Table…10 generations on · 2016
K163715 Allura Xper R910 generations on · 2017
K172822 Azurion series R1.211 generations on · 2017
K200917 Azurion R2.112 generations on · 2020

Most influential descendants

Showing 5 of 214 · See all

K972114Olympus Sonosurg SystemThe Olympus Optical Co. · 1998 · cites it directly213descendants
K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998 · 2 generations on175descendants
K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000 · 3 generations on157descendants
K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on154descendants
K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 5 generations on80descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K801623	Cavitron Ultrasonic Surg. Aspir. Cusa	Cavitron Corp.	1980	—
0 (this device)	K962952	Olympus Ultrasonic Surgical System (Usu)	Olympus Optical, Co.	1996	—
+1	K972114	Olympus Sonosurg System	The Olympus Optical Co.	1998	—
+2	K981993	Olympus Integrated Endosurgery System Endoalpha	The Olympus Optical Co.	1998	—
+3	K994231	Siemens Integrated Operating System (Sios)	Siemens Medical Corp.	2000	—
+4	K052202	Axiom Artis - Modular Angiographic System	Siemens Medical Solutions USA, Inc.	2006	29
+5	K061054	Axiom Aristos FX Plus	Siemens Medical Solutions USA, Inc.	2006	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1991	1	0
1992	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2000	1	0
2002	3	0
2003	6	0
2004	3	0
2005	6	0
2006	3	0
2007	2	0
2008	5	0
2009	4	0
2010	8	0
2011	6	0
2012	6	0
2013	12	0
2014	14	0
2015	9	0
2016	17	1
2017	9	2
2018	15	0
2019	8	0
2020	15	1
2021	11	0
2022	10	0
2023	8	0
2024	7	0
2025	14	0
2026	10	0

FIG. 1 — Lineage of K962952, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K801623	Cavitron Ultrasonic Surg. Aspir. Cusa Summary page 1 …l Name: Olympus USU Classification Name: Ultrasonic Surgical System/Ultrasonic Aspirator Predicate Devices: Cavitron Ultrasonic Surgical Aspirator CUSA® Type NS-100 (K#801623) CUSA® System 200c¢/200t/200m/200h Ultrasonic Aspirator (K#910696) CUSA® System 200c and 200t Ultrasonic Aspirator (K#9212561)…	Cavitron Corp.	1980	—
*	K910696	Cusa (R) System 200C/200T/200M/200H Ultra Aspirator Summary page 1 …m/Ultrasonic Aspirator Predicate Devices: Cavitron Ultrasonic Surgical Aspirator CUSA® Type NS-100 (K#801623) CUSA® System 200c¢/200t/200m/200h Ultrasonic Aspirator (K#910696) CUSA® System 200c and 200t Ultrasonic Aspirator (K#9212561) Cooper Laser Sonics CUSA® Model 200 (K#950945) Sharplan ULTRA Ultr…	Valleylab, Inc.	1991	—
*	K921251	Cusa System 200C and 200T Ultrasonic Aspirator Summary page 1 …t of Intended Use: The intended use of the Olympus USU s identlcai to the currently marketed CUSA® system 200 which was cleared for marketlng ln 510(k)#s K#910696 and K#921251. Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field. EXHIBIT #1 Page 2…	Valleylab, Inc.	1992	—
*	K950945	Cooper Laser Sonics Cusa Model 200 Summary page 1 …) CUSA® System 200c¢/200t/200m/200h Ultrasonic Aspirator (K#910696) CUSA® System 200c and 200t Ultrasonic Aspirator (K#9212561) Cooper Laser Sonics CUSA® Model 200 (K#950945) Sharplan ULTRA Ultrasonic Aspirator (K#883091) Prepared By: Mr. Yoshihita Bhimizy Manager Product Development Department Endosc…	Valleylab, Inc.	1995	—
*	K883091	Sharplan 4300 & 4310 Ultrasonic Surgical Apirators Summary page 1 …Aspirator (K#910696) CUSA® System 200c and 200t Ultrasonic Aspirator (K#9212561) Cooper Laser Sonics CUSA® Model 200 (K#950945) Sharplan ULTRA Ultrasonic Aspirator (K#883091) Prepared By: Mr. Yoshihita Bhimizy Manager Product Development Department Endoscape Divisian Qlympus Optlcal Ca., \|td. 29564 1s…	Sharplan Lasers, Inc.	1988	—

Also cleared against K801623: 3 other devices →

What descends from it? (214)

See all 214

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K972114	Olympus Sonosurg System	The Olympus Optical Co.	1998	213
K032066	Sonosurg System	The Olympus Optical Co.	2003	1
K041566	Sonosurg Ultrasonic Surgical System	Aomori Olympus Co., Ltd.	2004	0

Has anything in its family been recalled? (4 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 10 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 10 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 11 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 12 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

None of the 5 ancestors has a recall.
Of its descendants, K972114 (The Olympus Optical Co., 1998) has gone furthest, with 213 descendants of its own.
3 other devices also cite its predicate K801623.

How does its category compare?

All LBK devices

LBK Neurosurgical Ultrasonic Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBK

FDA has decided no LBK device since 2007.

Median 510(k) review, days · LBK

Too few LBK 510(k)s in any year since 2007 to give a median.

Recalls per year · LBK

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LBK

2in 2025

2007high 16 (2013) · low 0 (2009)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	3
2008	—	0	1
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	4
2013	—	1	16
2014	—	0	9
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	4
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

The Olympus Ultrasonic Surgical System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962952 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962952: Olympus Ultrasonic Surgical System (Usu).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962952

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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