510(k) · Cleared
ClearedCleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Devices, Inc. · KRA Catheter, Continuous Flush
Cleared on Apr 10, 2023 as substantially equivalent to K211798 (Argon Medical Devices, Inc., 2022) after a 181-day review. Its family tree reaches back 11 generations to 1995. 1 of the 30 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 10, 2023
- Review
- 181 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954234 (1995). 29 ancestors in all, the oldest K862691 (1986). No later device cites it as a predicate yet. 1 of the 30 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 7 generations between
- 3 generations backK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
- 2 generations backK141617 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
- 1 generation backK211798 Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022
- This deviceK223176 Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration…Argon Medical Devices, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 10 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 9 generations backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- 8 generations backK032569 Short Introducer SheathRex Medical · 2003
- 7 generations backK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- 6 generations backK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- 5 generations backK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- 4 generations backK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- 3 generations backK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
- 2 generations backK141617 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
- 1 generation backK211798 Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022
- This deviceK223176 Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration…Argon Medical Devices, Inc. · 2023
Class I recalls in this family
- K011056 Arrow-Trerotola Percutaneous Thrombolytic Device…4 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −10 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −9 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| −8 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| −7 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| −6 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| −5 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| −4 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| −3 | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
| −2 | K141617 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2014 | — |
| −1 | K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | 2022 | — |
| 0 (this device) | K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner… | Argon Medical Devices, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 1 |
| 2002 | 2 | 0 |
| 2003 | 2 | 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.
1 device in this family has a Class I recall. 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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 |
|---|---|---|---|
| * | K211798 | Cleaner Plus Thrombectomy SystemSummary page 4…21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices Predicate Primary: K211798 Cleaner Plus™ Thrombectomy System Device(s): Description of The Cleaner Plus™ Thrombectomy System is a single use devi… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K011056Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 29 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K211798.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223176: Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ 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/K223176
Report an extraction error
Are you the manufacturer?
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