510(k) · Cleared
ClearedSelector Quantum Ultrasonic Aspirator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences, Ltd. · LFL Instrument, Ultrasonic Surgical
Cleared on Sep 29, 2004 as substantially equivalent to K901974 (Spembly Medical, Ltd., 1990) and 4 other predicates after a 37-day review. Its family tree reaches back 3 generations to 1988. 17 later devices descend from it.
- Decided
- Sep 29, 2004
- Review
- 37 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K884413 (1988). 10 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 2 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 1 generation backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- This deviceK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
- Descendant · cites it directly · 16 of its ownK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 11 of its ownK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · Recalled
- Descendant · 3 generations on · 10 of its ownK182809 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · Recalled
- Descendant · 4 generations on · 5 of its ownK200774 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020
- Descendant · 5 generations on · 2 of its ownK221235 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · cites it directly16descendants
- K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · 2 generations on11descendants
- K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018 · 3 generations on10descendants
- K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020 · 4 generations on5descendants
- K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −2 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −1 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| 0 (this device) | K042277 | Selector Quantum Ultrasonic Aspirator System | Integra Neurosciences, Ltd. | 2004 | — |
| +1 | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | 2008 | 4 |
| +2 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016 | 2 |
| +3 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018 | 42 |
| +4 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020 | — |
| +5 | K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K901974 | Selector Ultrasonic Surgical AspiratorSummary page 2…tem is substantially equivalent to the following previously cleared and currently marketed devices: * Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, K021989) * CUSA Excel Ultrasonic Surgical Aspirator System (K981262) · Sonopet UST 2… | 1990 |
| * | K925129 | SelectorSummary page 2…bstantially equivalent to the following previously cleared and currently marketed devices: * Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, K021989) * CUSA Excel Ultrasonic Surgical Aspirator System (K981262) · Sonopet UST 2001 Ultra… | 1993 |
| * | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Summary page 2…uivalent to the following previously cleared and currently marketed devices: * Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, K021989) * CUSA Excel Ultrasonic Surgical Aspirator System (K981262) · Sonopet UST 2001 Ultrasonic Surgical Aspirat… | 2002 |
| * | K981262 | Cusa Excel Ultrasonic Surgical Aspirator SystemSummary page 2…ices: * Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, K021989) * CUSA Excel Ultrasonic Surgical Aspirator System (K981262) · Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K010309) D. Intended Use The SELECTOR® Quantum… | 1998 |
| * | K010309 | Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorSummary page 2…K925129, K021989) * CUSA Excel Ultrasonic Surgical Aspirator System (K981262) · Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K010309) D. Intended Use The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedu… | 2001 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | 2008 | 16 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K081459 (Integra Radionics, Inc., 2008) has gone furthest, with 16 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 | — |
What is it indicated for?
The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation emulsification and aspiration of soft 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042277: Selector Quantum Ultrasonic Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042277
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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