510(k) Report

510(k) · Cleared

Cleared

Omnisonics Ultrasonic Probes

K993628510(k) TraditionalCleared Dec 15, 199949-day reviewClass U

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

Omnisonics Medical Technologies · LFL Instrument, Ultrasonic Surgical

Cleared on Dec 15, 1999 as substantially equivalent to K990572 (Sonokinetics, Inc., 1999) and 7 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1988.

Decided
Dec 15, 1999
Review
49 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K884413 (1988). 12 ancestors in all, the oldest K853143 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1992: 1 other ancestorK884413 · Cusa System 200H Ultrasonic Surgical Aspirator · Valleylab, Inc. · 1988K981262 · Cusa Excel Ultrasonic Surgical Aspirator System · Valleylab, Inc. · 1998 · recalled1985199019952000
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 4 other ancestors K981262 · Cusa Excel Ultrasonic Surgical Aspirator System · Valleylab, Inc. · 1998 · recalledK884413 · Cusa System 200H Ultrasonic Surgical Aspirator · Valleylab, Inc. · 19880
  1. Root · 2 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
  2. 1 generation backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
  3. This deviceK993628 Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K884413Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc.1988—
−1K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc.19983
0 (this device)K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198810
199010
199110
199210
199420
199510
199910
FIG. 1 — Lineage of K993628, 1988–1999Source: 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
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What was it cleared against? (8)

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
*K990572Sonotome
Summary page 3
…parison of Technological Characteristics The OmniSonics Ultrasonic probes are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K990572) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). Ul…
Sonokinetics, Inc.1999—
*K853143Cooper Laser Sonics Cusa Model 200
Summary page 1
…mniSonics Ultrasonic probes are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation Th…
Cooper Lasersonics, Inc.1985—
*K864983Cusa System 200 Macro-Dissector
Summary page 1
…Ultrasonic probes are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation The OmniSon…
Cooper Lasersonics, Inc.1987—
*K884412Cusa System 200C,T & M Ultrasonic Surgical Aspira.
Summary page 1
…ic probes are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation The OmniSonics Ultra…
Valleylab, Inc.1988—
*K884413Cusa System 200H Ultrasonic Surgical Aspirator
Summary page 1
…are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation The OmniSonics Ultrasonic pro…
Valleylab, Inc.1988—
*K894600Cusa System 200C,T,M,H Ultrasonic Aspirator
Summary page 1
…tantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation The OmniSonics Ultrasonic probes work…
Valleylab, Inc.1990—
*K910696Cusa (R) System 200C/200T/200M/200H Ultra Aspirator
Summary page 1
…equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation The OmniSonics Ultrasonic probes work in conjun…
Valleylab, Inc.1991—
*K981262Cusa Excel Ultrasonic Surgical Aspirator System
Summary page 1
…dicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262). 4. Device Description Principle of Operation The OmniSonics Ultrasonic probes work in conjunction with the OmniSonics Ultras…
Valleylab, Inc.19983

Also cleared against K990572: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 1 other device also cites its predicate K990572.

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 intended use of the OmniSonics Ultrasonic Probes is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System.

The OmniSonics Ultrasonic Probes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the probe.

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

Also cleared against K990572

1 other device cites the same predicate.

  • K152699Apollo SystemPenumbra, Inc. · 2016

More from Omnisonics Medical Technologies

8 FDA decisions under this applicant name. See the company

  • K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
  • K071762Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
  • K052428Resolution Endovascular SystemOmnisonics Medical Technologies · 2005
  • K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004
  • K003824Omnisonics Ultrasonic Surgery System, Model StiOmnisonics Medical Technologies · 2001

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/K993628 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993628: Omnisonics Ultrasonic Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993628

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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