510(k) Report

510(k) · Cleared

Cleared

FlowTriever Retrieval/Aspiration System

K183198510(k) SpecialCleared Dec 17, 201828-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 Dec 17, 2018 after a 28-day review. The FDA summary names no predicate by number. 22 later devices descend from it.

Decided
Dec 17, 2018
Review
28 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
0

22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2025: 4 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2026: 5 descendants cleared2022: 1 descendant cleared2023: 6 descendants cleared201620182020202220242026
  1. This deviceK183198 FlowTriever Retrieval/Aspiration SystemInari Medical · 2018
  2. Descendant · cites it directly · 21 of its ownK191368 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
  3. Descendant · 2 generations on · 20 of its ownK191710 FlowTriever Retrieval/Aspiration SystemInari Medical · 2019
  4. Descendant · 3 generations on · 14 of its ownK202345 FlowTriever Retrieval/Aspiration SystemInari Medical · 2020
  5. Descendant · 4 generations on · 12 of its ownK211013 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters…Inari Medical, Inc. · 2021
  6. Descendant · 5 generations on · 9 of its ownK213402 Triever24, Triever20Inari Medical · 2022

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2019: 22020: 22021: 22022: 12023: 62025: 42026: 5
2019high 6 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 22 · See all
  • K191368FlowTriever Retrieval/Aspiration SystemInari Medical · 2019 · cites it directly21descendants
  • K191710FlowTriever Retrieval/Aspiration SystemInari Medical · 2019 · 2 generations on20descendants
  • K202345FlowTriever Retrieval/Aspiration SystemInari Medical · 2020 · 3 generations on14descendants
  • K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20…Inari Medical, Inc. · 2021 · 4 generations on12descendants
  • K213402Triever24, Triever20Inari Medical · 2022 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K183198FlowTriever Retrieval/Aspiration SystemInari Medical2018—
+1K191368FlowTriever Retrieval/Aspiration SystemInari Medical2019—
+2K191710FlowTriever Retrieval/Aspiration SystemInari Medical2019—
+3K202345FlowTriever Retrieval/Aspiration SystemInari Medical2020—
+4K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16…Inari Medical, Inc.2021—
+5K213402Triever24, Triever20Inari Medical2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202020
202120
202210
202360
202540
202650
FIG. 1 — Lineage of K183198, 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 K213402 Triever24, Triever20score 28.6 · 5 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?

The FDA summary names no predicate by number.

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191368FlowTriever Retrieval/Aspiration SystemInari Medical201921

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, K191368 (Inari Medical, 2019) has gone furthest, with 21 descendants of its own.

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. 2018, 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.

Indications for use as stated in the FDA summary.

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/K183198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183198: FlowTriever Retrieval/Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183198

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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