510(k) Report

510(k) · Cleared

Cleared

Sonotome

K990572510(k) TraditionalCleared May 21, 199987-day reviewClass U

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

Sonokinetics, Inc. · LFL Instrument, Ultrasonic Surgical

Cleared on May 21, 1999 as substantially equivalent to K930629 (Sonokinetics, Inc., 1994) and 6 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1985. 6 later devices descend from it.

Decided
May 21, 1999
Review
87 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K853143 (1985). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1988: 2 other ancestors1987: 1 other ancestor1999: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant clearedK853143 · Cooper Laser Sonics Cusa Model 200 · Cooper Lasersonics, Inc. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K853143 · Cooper Laser Sonics Cusa Model 200 · Cooper Lasersonics, Inc. · 19850
  1. Root · 1 generation backK853143 Cooper Laser Sonics Cusa Model 200Cooper Lasersonics, Inc. · 1985
  2. This deviceK990572 SonotomeSonokinetics, Inc. · 1999
  3. Descendant · cites it directly · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
  4. Descendant · 2 generations on · 2 of its ownK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
  5. Descendant · 3 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
  6. Descendant · 4 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
  7. Descendant · 2 generations on · 0 of its ownK181731 MR Compatible Aspiration KitMri Interventions, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999: 12016: 12017: 12018: 12020: 12023: 1
1999high 1 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all
  • K152699Apollo SystemPenumbra, Inc. · 2016 · cites it directly4descendants
  • K171332Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017 · 2 generations on2descendants
  • K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 3 generations on1descendant
  • K230125Neuroblade SystemClearmind Biomedical · 2023 · 4 generations on0descendants
  • K181731MR Compatible Aspiration KitMri Interventions, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K853143Cooper Laser Sonics Cusa Model 200Cooper Lasersonics, Inc.1985—
0 (this device)K990572SonotomeSonokinetics, Inc.1999—
+1K152699Apollo SystemPenumbra, Inc.2016—
+2K171332Artemis Neuro Evacuation DevicePenumbra, Inc.2017—
+3K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical2020—
+4K230125Neuroblade SystemClearmind Biomedical2023—
+2K181731MR Compatible Aspiration KitMri Interventions, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198820
199010
199110
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201610
201710
201810
202010
202310
FIG. 1 — Lineage of K990572, 1985–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (7)

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
*K930629Acryl-X II System
Summary page 1
…cs SONOTOME™ System is a mechanical ultrasonic surgical aspirator which is substantially equivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME…
Sonokinetics, Inc.1994—
*K853143Cooper Laser Sonics Cusa Model 200
Summary page 1
…surgical aspirator which is substantially equivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME™ System contains three subsystems: ultrasonic…
Cooper Lasersonics, Inc.1985—
*K864983Cusa System 200 Macro-Dissector
Summary page 1
…aspirator which is substantially equivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME™ System contains three subsystems: ultrasonic energy, i…
Cooper Lasersonics, Inc.1987—
*K884412Cusa System 200C,T & M Ultrasonic Surgical Aspira.
Summary page 1
…which is substantially equivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME™ System contains three subsystems: ultrasonic energy, irrigation…
Valleylab, Inc.1988—
*K884413Cusa System 200H Ultrasonic Surgical Aspirator
Summary page 1
…substantially equivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME™ System contains three subsystems: ultrasonic energy, irrigation and aspi…
Valleylab, Inc.1988—
*K894600Cusa System 200C,T,M,H Ultrasonic Aspirator
Summary page 1
…ially equivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME™ System contains three subsystems: ultrasonic energy, irrigation and aspiration. T…
Valleylab, Inc.1990—
*K910696Cusa (R) System 200C/200T/200M/200H Ultra Aspirator
Summary page 1
…ivalent to the following predicate devices: SonoKinetics’ ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696). 4. Device Description The SONOTOME™ System contains three subsystems: ultrasonic energy, irrigation and aspiration. The SONOTO…
Valleylab, Inc.1991—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K152699Apollo SystemPenumbra, Inc.20164
K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies19990

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?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K152699 (Penumbra, Inc., 2016) has gone furthest, with 4 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

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 SONOTOME System is intended for the following

indications:

Breakup and removal of soft tissues in Neurosurgery, GI and

affiliated organ surgery, Urology, General surgery, Plastic and

Reconstructive surgery, Orthopedic, GYN, Thoracic Surgery.

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

More from Sonokinetics, Inc.

3 FDA decisions under this applicant name. See the company

  • K930629Acryl-X II SystemSonokinetics, Inc. · 1994
  • K911548Acryl-X System TMSonokinetics, Inc. · 1991

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/K990572 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990572: Sonotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990572

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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