510(k) · Cleared
Recalled · Class II · 2026CUSA Clarity Ultrasonic Surgical Aspirator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · LFL Instrument, Ultrasonic Surgical
Cleared on Oct 14, 2016 as substantially equivalent to K141668 (Integra LifeSciences Corporation, 2014) and 1 other predicate after a 95-day review. Its family tree reaches back 5 generations to 1988. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 14, 2016
- Review
- 95 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K884413 (1988). 17 ancestors in all, the oldest K801623 (1980). 11 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 4 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 3 generations backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- 2 generations backK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
- 1 generation backK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
- This deviceK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016
- Descendant · cites it directly · 10 of its ownK182809 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK200774 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020
- Descendant · 3 generations on · 2 of its ownK221235 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK231117 neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 2023
- Descendant · 2 generations on · 1 of its ownK190180 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · cites it directly10descendants
- K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020 · 2 generations on5descendants
- K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022 · 3 generations on2descendants
- K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 2023 · 4 generations on1descendant
- K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −4 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −3 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| −2 | K042277 | Selector Quantum Ultrasonic Aspirator System | Integra Neurosciences, Ltd. | 2004 | — |
| −1 | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | 2008 | 4 |
| 0 (this device) | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016 | — |
| +1 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018 | 42 |
| +2 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020 | — |
| +3 | K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022 | — |
| +4 | K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | 2023 | — |
| +2 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K141668 | Cusa Excel+ Ultrasonic Surgical Aspirator SystemSummary page 4…Product Code(s) LFL, LBK 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668 CUSA® NXT Ultrasonic Tissue Ablation System K081459 K161882… | 2014 |
| * | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation SystemSummary page 4…(3) - Legally marketed device(s) to which equivalence is claimed CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668 CUSA® NXT Ultrasonic Tissue Ablation System K081459 K161882 Page 2/5 807.92(a)(4) - De… | 2008 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | 2018 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2026 | Class II | Z-1828-2026 | Under Investigation by firm | Software issue that renders the touch screen unresponsive. |
| Sep 26, 2017 | Class II | Z-0694-2018 | Process control | A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K182809 (Integra LifeSciences Corporation, 2018) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K141668.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Gastrointestinal and Affiliated Organ Surgery — including…
Read the full statement (167 words)
The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where
fragmentation, emulsification and aspiration of soft tissue is desirable.
The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery,
Gynecological Surgery and Thoracic Surgery and the following specific uses:
Gastrointestinal and Affiliated Organ Surgery — including removal of benign or malignant tumors or other unwanted
tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy
or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery — including removal of benign or malignant tumors or other unwanted soft tissue in open or
minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or
trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic
jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial
gastrectomy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161882: CUSA Clarity Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161882
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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