510(k) · Cleared
ClearedCusa System 200C/T Ultrasonic Aspirator & Access.
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 Sep 16, 1994 after a 515-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 90 later devices descend from it.
- Decided
- Sep 16, 1994
- Review
- 515 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
90 later devices descend from it, 1 citing it directly.
- This deviceK931902 Cusa System 200C/T Ultrasonic Aspirator & Access.Valleylab, Inc. · 1994
- Descendant · cites it directly · 89 of its ownK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 49 of its ownK991791 Sound Vaser SystemSound Surgical Technologies, LLC · 1999 · Recalled
- Descendant · 3 generations on · 48 of its ownK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- Descendant · 4 generations on · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · 5 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · cites it directly89descendants
- K991791Sound Vaser SystemSound Surgical Technologies, LLC · 1999 · 2 generations on49descendants
- K022051Soundvaser SystemSound Surgical Technologies, LLC · 2002 · 3 generations on48descendants
- K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · 4 generations on36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 5 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931902 | Cusa System 200C/T Ultrasonic Aspirator & Access. | Valleylab, Inc. | 1994 | — |
| +1 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| +2 | K991791 | Sound Vaser System | Sound Surgical Technologies, LLC | 1999 | 2 |
| +3 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| +4 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +5 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (90)
See all 901 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | 1998 | 89 |
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, K981262 (Valleylab, Inc., 1998) has gone furthest, with 89 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/K931902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K931902: Cusa System 200C/T Ultrasonic Aspirator & Access..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931902
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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