510(k) · Cleared
ClearedTriever16 Curve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Mar 23, 2023 as substantially equivalent to K213402 (Inari Medical, 2022) after a 133-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Mar 23, 2023
- Review
- 133 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K183198 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 5 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 4 generations backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 3 generations backK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
- 2 generations backK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
- 1 generation backK213402 Triever24, Triever20Inari Medical · 2022
- This deviceK223419 Triever16 CurveInari Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −5 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −4 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −3 | K202345 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2020 | — |
| −2 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16… | Inari Medical, Inc. | 2021 | — |
| −1 | K213402 | Triever24, Triever20 | Inari Medical | 2022 | — |
| 0 (this device) | K223419 | Triever16 Curve | Inari Medical | 2023 | — |
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 QEW? 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 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 |
|---|---|---|---|
| * | K213402 | Triever24, Triever20Summary page 4…R 870.5150 Product code QEW Secondary product KRA code Regulatory class II Predicate device Inari FlowTriever Retrieval/Aspiration System (K213402) References devices Penumbra Indigo System Aspiration Catheter 12 (K192981) Description The Triever16 (“T16”) Cu… | 2022 |
| † | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 6 ancestors has a recall.
- 7 other devices also cite its predicate K213402.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The Trieverl6 Curve is indicated for:
* The non-surgical removal of emboli and thrombi from blood vessels.
* Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Trieverl6 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Trieverl6 Curve is not indicated for use with FlowTriever Catheters.
The Trieverl6 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223419 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223419: Triever16 Curve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223419
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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