510(k) · Cleared
ClearedCusa System 200C,T,M,H Ultrasonic Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Jan 19, 1990 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 19, 1990
- Review
- 183 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK894600 Cusa System 200C,T,M,H Ultrasonic AspiratorValleylab, Inc. · 1990
- Descendant · cites it directly · 6 of its ownK990572 SonotomeSonokinetics, Inc. · 1999
- Descendant · 2 generations on · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
- Descendant · 5 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K990572SonotomeSonokinetics, Inc. · 1999 · cites it directly6descendants
- K152699Apollo SystemPenumbra, Inc. · 2016 · 2 generations on4descendants
- K171332Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017 · 3 generations on2descendants
- K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 4 generations on1descendant
- K230125Neuroblade SystemClearmind Biomedical · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894600 | Cusa System 200C,T,M,H Ultrasonic Aspirator | Valleylab, Inc. | 1990 | — |
| +1 | K990572 | Sonotome | Sonokinetics, Inc. | 1999 | — |
| +2 | K152699 | Apollo System | Penumbra, Inc. | 2016 | — |
| +3 | K171332 | Artemis Neuro Evacuation Device | Penumbra, Inc. | 2017 | — |
| +4 | K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | 2020 | — |
| +5 | K230125 | Neuroblade System | Clearmind Biomedical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
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
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? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K990572 (Sonokinetics, Inc., 1999) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K894600 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894600: Cusa System 200C,T,M,H 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/K894600
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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