510(k) · Cleared
ClearedCLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Devices, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Feb 5, 2026 as substantially equivalent to K232679 (Argon Medical Devices, Inc., 2024) after a 31-day review. Its family tree reaches back 16 generations to 2001.
- Decided
- Feb 5, 2026
- Review
- 31 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K003410 (2001). 27 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 16 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 12 generations between
- 3 generations backK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
- 2 generations backK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
- 1 generation backK232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter…Argon Medical Devices, Inc. · 2024
- This deviceK260028 CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter…Argon Medical Devices, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 15 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 14 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 13 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 12 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 11 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 10 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 9 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 8 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 7 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 6 generations backK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- 5 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 4 generations backK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
- 3 generations backK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
- 2 generations backK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
- 1 generation backK232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter…Argon Medical Devices, Inc. · 2024
- This deviceK260028 CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter…Argon Medical Devices, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −15 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −14 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −13 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −12 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −11 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −10 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −9 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −8 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −7 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| −6 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -… | Penumbra, Inc. | 2018 | — |
| −5 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018 | — |
| −4 | K193244 | Indigo Aspiration System – Lightning Aspiration Tubing | Penumbra, Inc. | 2020 | — |
| −3 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | 2021 | — |
| −2 | K222358 | Indigo Aspiration System - Lightning Flash | Penumbra, Inc. | 2022 | — |
| −1 | K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with… | Argon Medical Devices, Inc. | 2024 | — |
| 0 (this device) | K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with… | Argon Medical Devices, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 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 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 K213402 Triever24, Triever20score 28.6 · 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 |
|---|---|---|---|
| * | K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Summary page 5…21 §CFR 870.5150 Class II Review Panel: Cardiovascular Devices Predicate Primary – K232679, Cleaner Pro™ Thrombectomy System, Cleaner Pro™ Aspiration Device(s): Canister, Cleaner Pro™ Aspiration Canister wi… | 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 1.7 years on median.
- 9 of the 27 ancestors have a recall of any class.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The CLEANER™ Vac Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The CLEANER™ Vac Thrombectomy System is not intended for use in the pulmonary vasculature for treating pulmonary embolism.
The CLEANER™ Vac Aspiration Canister is indicated as a vacuum source for the CLEANER™ Vac Thrombectomy System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260028: CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260028
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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