510(k) · Cleared
ClearedKogent Torus Ultrasonic Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Katalyst Surgical, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Jun 19, 2020 as substantially equivalent to K190070 (Stryker Corporation, 2019) and 1 other predicate after a 240-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 19, 2020
- Review
- 240 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010309 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK010309 Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorMutoh America Co., Ltd. · 2001 · Recalled
- This deviceK192963 Kogent Torus Ultrasonic AspiratorKatalyst Surgical, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010309 | Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator | Mutoh America Co., Ltd. | 2001 | 4 |
| 0 (this device) | K192963 | Kogent Torus Ultrasonic Aspirator | Katalyst Surgical, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K190070 | Sonopet iQ Ultrasonic Aspirator SystemSummary page 5…mmodates most commercially available suction canisters and optional specimen traps. Predicate Devices: 510(k) Company Name Device Name K190070 Stryker Instruments Sonopet iQ Ultrasonic Surgical Aspirator K010309 MUTOH America Co. Sonopet Model U… | 2019 |
| * | K010309 | Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorSummary page 5…s. Predicate Devices: 510(k) Company Name Device Name K190070 Stryker Instruments Sonopet iQ Ultrasonic Surgical Aspirator K010309 MUTOH America Co. Sonopet Model UST-2001 Ultrasonic Surgical Aspirator Comparison of Technical Characteristics:… | 2001 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K190070.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 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 | — |
What is it indicated for?
The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192963: Kogent Torus Ultrasonic Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192963
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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