510(k) · Cleared
ClearedJETi AIO Peripheral Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walk Vascular, LLC · QEZ Aspiration Thrombectomy Catheter
Cleared on Feb 1, 2022 as substantially equivalent to K201998 (Walk Vascular, LLC, 2020) after an 84-day review. Its family tree reaches back 2 generations to 2019. 1 later device descends from it.
- Decided
- Feb 1, 2022
- Review
- 84 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183403 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK183403 JETi 88 Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019
- 1 generation backK201998 JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2020
- This deviceK213565 JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2022
- Descendant · cites it directly · 0 of its ownK232458 JETi™Hydrodynamic Thrombectomy SystemAbbott Medical · 2023
Most influential descendants
Showing 1 of 1 · See all- K232458JETi™Hydrodynamic Thrombectomy SystemAbbott Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | 2019 | — |
| −1 | K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2020 | — |
| 0 (this device) | K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2022 | — |
| +1 | K232458 | JETi™Hydrodynamic Thrombectomy System | Abbott Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 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 |
|---|---|---|---|
| * | K201998 | JETi AIO Peripheral Thrombectomy SystemSummary page 4…atheter (21 CFR 870.5150) Product Code: QEZ Predicate Device: JETi AIO Peripheral Thrombectomy System (510(k) K201998) Device Description: The JETi All In One (AIO) Peripheral Thrombectomy System consists of one catheter, which is connected to th… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232458 | JETi™Hydrodynamic Thrombectomy System | 2023 | 0 |
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 3 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232458 (Abbott Medical, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The JETi AIO Peripheral Thrombectomy System is intended to:
- remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213565: JETi AIO Peripheral Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213565
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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