510(k) · Cleared
ClearedTriever20 Curve Catheter
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 Dec 10, 2020 as substantially equivalent to K191710 (Inari Medical, 2019) after a 28-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Dec 10, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183198 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
- 2 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- 1 generation backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
- This deviceK203333 Triever20 Curve CatheterInari Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2018 | — |
| −2 | K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| −1 | K191710 | FlowTriever Retrieval/Aspiration System | Inari Medical | 2019 | — |
| 0 (this device) | K203333 | Triever20 Curve Catheter | Inari Medical, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K191710 | FlowTriever Retrieval/Aspiration SystemSummary page 4…Classification number 21 CFR 870.5150 Product code QEW Regulatory class II Predicate device Inari FlowTriever Retrieval/Aspiration System (K191710) Description The Triever20 Curve is a single-use over-the-wire catheter used for the minimally… | 2019 |
| † | K173672 | FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter | 2018 |
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 2 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K191710.
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. 2020, 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 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 is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Triever20 Curve Catheter is not indicated for use with FlowTriever Catheters.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203333: Triever20 Curve Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203333
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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