510(k) · Cleared
ClearedFLOWRUNNER Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Expanse Medical, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Mar 20, 2026 as substantially equivalent to K251488 (Expanse Medical, Inc., 2025) after an 81-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- Mar 20, 2026
- Review
- 81 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K003410 (2001). 16 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 14 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 10 generations between
- 3 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 2 generations backK234073 ICE Aspiration SystemExpanse Medical, Inc. · 2024
- 1 generation backK251488 FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2025
- This deviceK254208 FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 13 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 12 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 11 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 10 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 9 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 8 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 7 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 6 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 5 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 4 generations backK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- 3 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 2 generations backK234073 ICE Aspiration SystemExpanse Medical, Inc. · 2024
- 1 generation backK251488 FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2025
- This deviceK254208 FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −13 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −12 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −11 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −10 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −9 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −8 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −7 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −6 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −5 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| −4 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -… | Penumbra, Inc. | 2018 | — |
| −3 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018 | — |
| −2 | K234073 | ICE Aspiration System | Expanse Medical, Inc. | 2024 | — |
| −1 | K251488 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2025 | — |
| 0 (this device) | K254208 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K251488 | FLOWRUNNER Aspiration SystemSummary page 5…mbolectomy Catheter Regulatory Class: Class II Product Code: QEZ and KRA Predicate Device: FLOWRUNNER Aspiration System (K251488) 3. Indication for Use The FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and… | 2025 |
| † | K234073 | ICE Aspiration System | 2024 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 16 ancestors have a recall of any class.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254208: FLOWRUNNER 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/K254208
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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