510(k) · Cleared

Recalled · Class II · 2014

Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator

K010309510(k) TraditionalCleared Apr 18, 200176-day reviewClass URecalls 4

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

Mutoh America Co., Ltd. · LFL Instrument, Ultrasonic Surgical

Cleared on Apr 18, 2001 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it. It has been recalled 4 times.

Decided: Apr 18, 2001
Review: 76 days
Class: Class U
Product code: LFL
Recalls: 4
Predicates: 0

27 later devices descend from it, 5 citing it directly.

This deviceK010309 Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorMutoh America Co., Ltd. · 2001
Descendant · cites it directly · 23 of its ownK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
Descendant · 2 generations on · 17 of its ownK071669 Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007
Descendant · cites it directly · 17 of its ownK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
Descendant · 2 generations on · 16 of its ownK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
Descendant · 3 generations on · 11 of its ownK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2002high 4 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 27 · See all

K021989Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · cites it directly23descendants
K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007 · 2 generations on17descendants
K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004 · cites it directly17descendants
K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · 2 generations on16descendants
K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · 3 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010309	Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator	Mutoh America Co., Ltd.	2001	—
+1	K021989	Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3	Integra Neurosciences	2002	2
+2	K071669	Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip	Integra Radionics, Inc.	2007	—
+1	K042277	Selector Quantum Ultrasonic Aspirator System	Integra Neurosciences, Ltd.	2004	—
+2	K081459	Cusa Selector NXT Ultrasonic Tissue Ablation System	Integra Radionics, Inc.	2008	4
+3	K161882	CUSA Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	2016	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2016	2	0
2018	1	0
2019	1	0
2020	2	0
2022	4	0
2023	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K010309, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K021989	Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3	Integra Neurosciences	2002	23
K042277	Selector Quantum Ultrasonic Aspirator System	Integra Neurosciences, Ltd.	2004	17
K032066	Sonosurg System	The Olympus Optical Co.	2003	1
K192963	Kogent Torus Ultrasonic Aspirator	Katalyst Surgical, LLC	2020	0
K041566	Sonosurg Ultrasonic Surgical System	Aomori Olympus Co., Ltd.	2004	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2014	Class II	Z-2156-2014	Labeling design	The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
Jun 24, 2013	Class II	Z-1878-2013	Component change control	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power…
Jun 24, 2013	Class II	Z-1880-2013	Component change control	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power…
Jun 24, 2013	Class II	Z-1879-2013	Component change control	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K021989 (Integra Neurosciences, 2002) has gone furthest, with 23 descendants of its own.

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

2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007high 241 (2011) · low 66 (2018)2026

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

Recalls per year · LFL

11in 2024

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

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

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	—

https://510kreport.com/device/K010309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010309: Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010309

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026