510(k) · Cleared
ClearedIntegra Selector Ultrasonic Surgical Aspirator System with Bone Tip
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 17, 2007 as substantially equivalent to K021989 (Integra Neurosciences, 2002) and 2 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1988. 17 later devices descend from it.
- Decided
- Aug 17, 2007
- Review
- 59 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884413 (1988). 11 ancestors in all, the oldest K801623 (1980). 17 later devices descend from it, 3 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 deviceK071669 Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007
- 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) | K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip | Integra Radionics, Inc. | 2007 | — |
| +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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 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? (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 |
|---|---|---|---|
| * | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Summary page 1…cal. The product code is LFL. 3.0 The above device is substantial equivalent to: * Selector Integra Ultrasonic Surgical Aspirator System cleared via 5 10(k) K021989 on September 13, 2002. * Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip cleared via 510(k) K0… | 2002 |
| * | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneSummary page 1…System cleared via 5 10(k) K021989 on September 13, 2002. * Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip cleared via 510(k) K051947 on August 22, 2005. • Synergetics Sonotome Ultrasonic Aspirator Tips was cleared via the 510(k) process, K020220, on A… | 2005 |
| * | K020220 | Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring CurretteSummary page 1…ystem with Bone Tip cleared via 510(k) K051947 on August 22, 2005. • Synergetics Sonotome Ultrasonic Aspirator Tips was cleared via the 510(k) process, K020220, on August 23, 2002. 4.0 The Selector Integra Ultrasonic Surgical Aspirator System (Selector) is an ultrasonically vibrating… | 2002 |
What descends from it? (17)
See all 173 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K081459 (Integra Radionics, Inc., 2008) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K021989.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Selector 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/K071669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071669: Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071669
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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