510(k) · Cleared
ClearedCleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro 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 Jan 19, 2024 as substantially equivalent to K222358 (Penumbra, Inc., 2022) after a 140-day review. Its family tree reaches back 15 generations to 2001. 1 later device descends from it.
- Decided
- Jan 19, 2024
- Review
- 140 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K003410 (2001). 26 ancestors in all, the oldest K010853 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 11 generations between
- 3 generations backK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
- 2 generations backK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
- 1 generation backK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
- This deviceK232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter…Argon Medical Devices, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260028 CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter…Argon Medical Devices, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 14 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 13 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 12 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 11 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 10 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 9 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 8 generations backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- 7 generations backK160533 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. · 2016
- 6 generations backK161523 INDIGO Aspiration SystemPenumbra, Inc. · 2016
- 5 generations backK180105 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration…Penumbra, Inc. · 2018
- 4 generations backK180939 Indigo Aspiration System - Modified 110 Aspiration TubingPenumbra, Inc. · 2018
- 3 generations backK193244 Indigo Aspiration System – Lightning Aspiration TubingPenumbra, Inc. · 2020
- 2 generations backK210323 Indigo Aspiration System - Lightning Aspiration TubingPenumbra, Inc. · 2021
- 1 generation backK222358 Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
- This deviceK232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter…Argon Medical Devices, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece…Argon Medical Devices, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −14 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −13 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −12 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −11 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −10 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −9 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −8 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| −7 | K160533 | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) | Penumbra, Inc. | 2016 | — |
| −6 | K161523 | INDIGO Aspiration System | Penumbra, Inc. | 2016 | — |
| −5 | K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System -… | Penumbra, Inc. | 2018 | — |
| −4 | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | Penumbra, Inc. | 2018 | — |
| −3 | K193244 | Indigo Aspiration System – Lightning Aspiration Tubing | Penumbra, Inc. | 2020 | — |
| −2 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | Penumbra, Inc. | 2021 | — |
| −1 | K222358 | Indigo Aspiration System - Lightning Flash | Penumbra, Inc. | 2022 | — |
| 0 (this device) | K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with… | Argon Medical Devices, Inc. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K222358 | Indigo Aspiration System - Lightning FlashSummary page 4…21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices Predicate Device: K222358 Indigo® Aspiration System – Lighting® Flash Predicate Device: Reference Device: K223176 Cleaner Plus™… | 2022 |
| † | K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™… | 2023 |
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 |
|---|---|---|---|
| K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece… | 2026 | 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 23 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 26 ancestors have a recall of any class.
- Of its descendants, K260028 (Argon Medical Devices, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K222358.
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. 2024, 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 Cleanerm Pro 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 CleanerTm Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary
embolism.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232679: Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232679
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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