510(k) Report

510(k) · Cleared

Cleared

Triever24, Triever20

K213402510(k) SpecialCleared May 23, 2022217-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inari Medical · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on May 23, 2022 as substantially equivalent to K211013 (Inari Medical, Inc., 2021) after a 217-day review. Its family tree reaches back 5 generations to 2018. 9 later devices descend from it.

Decided
May 23, 2022
Review
217 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K183198 (2018). 9 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2023: 4 descendants cleared2025: 3 descendants cleared2026: 2 descendants clearedK183198 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2018K191368 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2019K191710 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2019K202345 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2020K211013 · FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 · Inari Medical, Inc. · 2021201620182020202220242026
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 1 descendant K211013 · FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 · Inari Medical, Inc. · 2021K202345 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2020K191710 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2019K191368 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2019K183198 · FlowTriever Retrieval/Aspiration System · Inari Medical · 2018−50
  1. Root · 5 generations backK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
  2. 4 generations backK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
  3. 3 generations backK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
  4. 2 generations backK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
  5. 1 generation backK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
  6. This deviceK213402 Triever24, Triever20Inari Medical · 2022
  7. Descendant · cites it directly · 1 of its ownK223897 Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023
  8. Descendant · cites it directly · 0 of its ownK253419 Triever Duo CatheterInari Medical, Inc. · 2026
  9. Descendant · cites it directly · 0 of its ownK254035 Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro · 2026
  10. Descendant · cites it directly · 0 of its ownK252508 Intri26 Introducer SheathInari Medical, Inc. · 2025
  11. Descendant · cites it directly · 0 of its ownK252509 AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2023: 42025: 32026: 2
2023high 4 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 9 · See all
  • K223897Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023 · cites it directly1descendant
  • K253419Triever Duo CatheterInari Medical, Inc. · 2026 · cites it directly0descendants
  • K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro · 2026 · cites it directly0descendants
  • K252508Intri26 Introducer SheathInari Medical, Inc. · 2025 · cites it directly0descendants
  • K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K183198FlowTriever Retrieval/Aspiration SystemInari Medical2018—
−4K191368FlowTriever Retrieval/Aspiration SystemInari Medical2019—
−3K191710FlowTriever Retrieval/Aspiration SystemInari Medical2019—
−2K202345FlowTriever Retrieval/Aspiration SystemInari Medical2020—
−1K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16…Inari Medical, Inc.2021—
0 (this device)K213402Triever24, Triever20Inari Medical2022—
+1K223897Excipio LV Thrombectomy DeviceContego Medical, Inc.2023—
+1K253419Triever Duo CatheterInari Medical, Inc.2026—
+1K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro2026—
+1K252508Intri26 Introducer SheathInari Medical, Inc.2025—
+1K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202340
202530
202620
FIG. 1 — Lineage of K213402, 2018–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212632 ClotTriever Thrombectomy Systemscore 27.7 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20…
Summary page 4
…FR 870.5150 Primary product code QEW Secondary product code KRA Regulatory class II Predicate device Inari FlowTriever Retrieval/Aspiration System (K211013) The Triever20 (K182233) was subject to a design-related recall (Z-2299-2020),…
Inari Medical, Inc.2021—

Also cleared against K211013: 1 other device →

What descends from it? (9)

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K223897Excipio LV Thrombectomy DeviceContego Medical, Inc.20231
K253419Triever Duo CatheterInari Medical, Inc.20260
K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro20260
K252508Intri26 Introducer SheathInari Medical, Inc.20250
K252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.20250
K231848Triever20 Curve (21-201)Inari Medical, Inc.20230
K223419Triever16 CurveInari Medical20230
K223436Artix AXInari Medical20230

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 4 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K223897 (Contego Medical, Inc., 2023) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K211013.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · QEW

14in 2025

2008: 22009: 22012: 12013: 22014: 22015: 42016: 42017: 22018: 142019: 82020: 162021: 112022: 122023: 232024: 142025: 142026 (partial year): 10
2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2015: 88 days median2016: 63 days median2018: 61 days median2019: 51 days median2020: 105 days median2021: 60 days median2022: 140 days median2023: 102 days median2024: 65 days median2025: 58 days median2026 (partial year): 74 days median
2007high 140 (2022) · low 51 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEW

7in 2022

2022: 7, 7 Class I
2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2019: 332020: 1972021: 3222022: 1252023: 1652024: 1622025: 207
2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20092—00
20100—00
20110—00
20121—00
20132—00
20142—00
201548800
201646300
20172—00
2018146100
2019851033
2020161050197
202111600322
2022121407 (7)125
2023231020165
202414650162
202514580207
202610740—

What is it indicated for?

The FlowTriever Retrieval/Aspiration System 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 FlowTriever Retrieval/Aspiration system is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

Triever Catheters are 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.

Also cleared against K211013

1 other device cites the same predicate.

  • K223929Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)Innova Vascular, Inc. · 2023

More from Inari Medical

26 FDA decisions under this applicant name. See the company

  • K253323Protrieve SheathInari Medical · 2025
  • K230912Artix BGInari Medical · 2023
  • K223419Triever16 CurveInari Medical · 2023
  • K223436Artix AXInari Medical · 2023
  • K223000Artix BGInari Medical · 2023

Recent decisions in QEW

The QEW category page

  • K262904INDIGO® Aspiration SystemPenumbra, Inc. · 2026
  • K253419Triever Duo CatheterInari Medical, Inc. · 2026
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
  • K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
  • K261523Vertex™ Thrombectomy SystemJupiter Endovascular · 2026

https://510kreport.com/device/K213402 · printed Nov 4, 2026

Cite this page

510(k) Report. “K213402: Triever24, Triever20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213402

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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