510(k) · Cleared
ClearedTriever20 Curve (21-201)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inari Medical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jul 21, 2023 as substantially equivalent to K213402 (Inari Medical, 2022) after a 28-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Jul 21, 2023
- Review
- 28 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 deviceK231848 Triever20 Curve (21-201)Inari Medical, Inc. · 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) | K231848 | Triever20 Curve (21-201) | Inari Medical, Inc. | 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…er Product code QEW Secondary Product KRA Code Regulatory class II Predicate device Inari Medical, Inari FlowTriever Retrieval/ Aspiration System (K213402) This device has not been subject to a design-related recall. Reference device Inari Medical, Triever2… | 2022 |
| † | K203333 | Triever20 Curve Catheter | 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 1.1 years 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 Triever20 Curve (21-201) is used coaxially within the Triever24 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 Triever20 Curve (21-201) is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve (21-201) Catheter is not indicated for use with FlowTriever Catheters.
Triever20 Curve (21-201) is also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever Catheters.
The Triever20 Curve (21-201) must be used within the Triever24.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231848: Triever20 Curve (21-201).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231848
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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