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 Apr 11, 2019 after an 86-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Apr 11, 2019
- Review
- 86 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK190070 Sonopet iQ Ultrasonic Aspirator SystemStryker Corporation · 2019
- Descendant · cites it directly · 2 of its ownK213824 Sonopet iQ Ultrasonic Aspirator SystemStryker Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK243930 Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker Instruments · 2025
- Descendant · 2 generations on · 0 of its ownK223770 Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
- Descendant · cites it directly · 0 of its ownK192963 Kogent Torus Ultrasonic AspiratorKatalyst Surgical, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K213824Sonopet iQ Ultrasonic Aspirator SystemStryker Corporation · 2022 · cites it directly2descendants
- K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker Instruments · 2025 · 2 generations on0descendants
- K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023 · 2 generations on0descendants
- K192963Kogent Torus Ultrasonic AspiratorKatalyst Surgical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190070 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2019 | — |
| +1 | K213824 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2022 | — |
| +2 | K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments | 2025 | — |
| +2 | K223770 | Sonopet 1Q 3 7cm 1Q Large | Stryker Corporation | 2023 | — |
| +1 | K192963 | Kogent Torus Ultrasonic Aspirator | Katalyst Surgical, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K213824 (Stryker Corporation, 2022) has gone furthest, with 2 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. 2019, 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 | — |
https://510kreport.com/device/K190070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190070: Sonopet iQ Ultrasonic Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190070
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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