510(k) · Cleared
ClearedSonopet iQ Ultrasonic Aspirator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · LFL Instrument, Ultrasonic Surgical
Cleared on Feb 3, 2022 as substantially equivalent to K190070 (Stryker Corporation, 2019) after a 57-day review. Its family tree reaches back 1 generation to 2019. 2 later devices descend from it.
- Decided
- Feb 3, 2022
- Review
- 57 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190070 (2019). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK190070 Sonopet iQ Ultrasonic Aspirator SystemStryker Corporation · 2019
- This deviceK213824 Sonopet iQ Ultrasonic Aspirator SystemStryker Corporation · 2022
- Descendant · cites it directly · 0 of its ownK243930 Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker Instruments · 2025
- Descendant · cites it directly · 0 of its ownK223770 Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190070 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2019 | — |
| 0 (this device) | K213824 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2022 | — |
| +1 | K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments | 2025 | — |
| +1 | K223770 | Sonopet 1Q 3 7cm 1Q Large | Stryker Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K190070 | Sonopet iQ Ultrasonic Aspirator SystemSummary page 4…Predicate Device Trade Name 510(k) Product Code Manufacturer Sonopet iQ Ultrasonic Aspirator K190070 LFL Stryker Instruments System Indications for Use The Sonopet iQ Ultrasonic Aspirator S… | 2019 |
What descends from it? (2)
2 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?
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue and hard 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.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213824 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213824: Sonopet iQ 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/K213824
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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