510(k) · Cleared
ClearedJETi™Hydrodynamic Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · QEZ Aspiration Thrombectomy Catheter
Cleared on Dec 19, 2023 as substantially equivalent to K213565 (Walk Vascular, LLC, 2022) after a 126-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Dec 19, 2023
- Review
- 126 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183403 (2019). No later device cites it as a predicate yet.
- Root · 3 generations backK183403 JETi 88 Peripheral Thrombectomy SystemWalk Vascular, LLC · 2019
- 2 generations backK201998 JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2020
- 1 generation backK213565 JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC · 2022
- This deviceK232458 JETi™Hydrodynamic Thrombectomy SystemAbbott Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | 2019 | — |
| −2 | K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2020 | — |
| −1 | K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2022 | — |
| 0 (this device) | K232458 | JETi™Hydrodynamic Thrombectomy System | Abbott Medical | 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 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 |
|---|---|---|---|
| * | K213565 | JETi AIO Peripheral Thrombectomy SystemSummary page 4…CFR 870.5150) Name Primary Procode QEZ Secondary KDQ, FOX Procodes Predicate Device Predicate Device: JETi All In One (AIO) Peripheral Thrombectomy System, K213565, Reference Device: JETi All In One (AIO) Peripheral Thrombectomy System, K201988 Device The JETi™… | 2022 |
| † | K201988 | T-Lite | 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 4 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232458: JETi™Hydrodynamic 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/K232458
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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