510(k) · Cleared
Recalled · 2005Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences · LFL Instrument, Ultrasonic Surgical
Cleared on Sep 13, 2002 as substantially equivalent to K981262 (Valleylab, Inc., 1998) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1988. 23 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 13, 2002
- Review
- 87 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K884413 (1988). 7 ancestors in all. 23 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 1 generation backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- This deviceK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002
- Descendant · cites it directly · 17 of its ownK071669 Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK042277 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
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007 · cites it directly17descendants
- K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −1 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| 0 (this device) | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | — |
| +1 | K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip | Integra Radionics, Inc. | 2007 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 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 |
|---|---|---|---|
| * | K981262 | Cusa Excel Ultrasonic Surgical Aspirator SystemSummary page 1…ator System is substantially equivalent to the following previously cleared and currently marketed devices: CUSA Excel Ultrasonic Surgical Aspirator System (K98 1262) Sonotom 110 Ultrasonic Aspirator System (KO10637) Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K0103… | 1998 |
| * | K010637 | Sonotome Ultrasonic Aspirator Tips | 2001 |
| * | K010309 | Sonopet Model Ust-2001 Ultrasonic Surgical AspiratorSummary page 1…ltrasonic Surgical Aspirator System (K98 1262) Sonotom 110 Ultrasonic Aspirator System (KO10637) Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K010309) A- 1 D. Intended Use The S… | 2001 |
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip | 2007 | 17 |
| K042277 | Selector Quantum Ultrasonic Aspirator System | 2004 | 17 |
| K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | 2008 | 16 |
| K101561 | TX1 Tissue Removal System | 2010 | 3 |
| K102258 | Cusa NXT Extended Length Tip | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2005 | Not classified | Z-0431-06 | Other | Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6) |
| Sep 13, 2005 | Not classified | Z-0141-06 | Other | Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K071669 (Integra Radionics, Inc., 2007) has gone furthest, with 17 descendants of its own.
- 10 other devices also cite its predicate K981262.
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@ Integra 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 as stated in the FDA summary.
https://510kreport.com/device/K021989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021989: Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021989
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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