510(k) · Cleared
Recalled · Class II · 2014Cusa Selector NXT Ultrasonic Tissue Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Radionics, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Aug 13, 2008 as substantially equivalent to K071669 (Integra Radionics, Inc., 2007) and 2 other predicates after an 82-day review. Its family tree reaches back 4 generations to 1988. 16 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 13, 2008
- Review
- 82 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K884413 (1988). 15 ancestors in all, the oldest K801623 (1980). 16 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 3 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 2 generations backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- 1 generation backK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
- This deviceK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK182809 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · Recalled
- Descendant · 3 generations on · 5 of its ownK200774 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020
- Descendant · 4 generations on · 2 of its ownK221235 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK102258 Cusa NXT Extended Length TipIntegra Radionics, Inc. · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · cites it directly11descendants
- K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · 2 generations on10descendants
- K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020 · 3 generations on5descendants
- K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022 · 4 generations on2descendants
- K102258Cusa NXT Extended Length TipIntegra Radionics, Inc. · 2011 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −3 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −2 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| −1 | K042277 | Selector Quantum Ultrasonic Aspirator System | Integra Neurosciences, Ltd. | 2004 | — |
| 0 (this device) | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | 2008 | — |
| +1 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016 | 2 |
| +2 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018 | 42 |
| +3 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020 | — |
| +4 | K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022 | — |
| +1 | K102258 | Cusa NXT Extended Length Tip | Integra Radionics, Inc. | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone TipSummary page 1…The technological characteristics are similar to those found in the following predicate devices: Selector Ultrasonic Surgical Aspirator with Bone Tip cleared via 5 10(k) K071669 on August 17, 2007, Selector Quantum Ultrasonic Surgical Aspirator cleared via 5 10(k) K042277 on September 29, 2004, and Selecto… | 2007 |
| * | K042277 | Selector Quantum Ultrasonic Aspirator SystemSummary page 1…: Selector Ultrasonic Surgical Aspirator with Bone Tip cleared via 5 10(k) K071669 on August 17, 2007, Selector Quantum Ultrasonic Surgical Aspirator cleared via 5 10(k) K042277 on September 29, 2004, and Selector Integra Ultrasonic Surgical Aspirator System cleared via 510(k) K021989 on September 13, 2002… | 2004 |
| * | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Summary page 1…tor Quantum Ultrasonic Surgical Aspirator cleared via 5 10(k) K042277 on September 29, 2004, and Selector Integra Ultrasonic Surgical Aspirator System cleared via 510(k) K021989 on September 13, 2002. The CUSA Selector NXT Ultrasonic Surgical Aspirator consists of two components: System Console and Servic… | 2002 |
What descends from it? (16)
See all 164 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2014 | Class II | Z-0491-2015 | Device Design | Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner. |
| May 2, 2011 | Not classified | Z-2585-2011 | Device Design | The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the… |
| Jul 29, 2010 | Not classified | Z-2638-2010 | Device Design | A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess… |
| Jul 29, 2010 | Not classified | Z-2637-2010 | Device Design | A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K161882 (Integra LifeSciences Corporation, 2016) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K071669.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 SelectorTM NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, 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/K081459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081459
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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