510(k) · Cleared
ClearedCleaner Rotational Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Medical · MCW Catheter, Peripheral, Atherectomy
Cleared on Jun 1, 2012 as substantially equivalent to K091029 (Rex Medical, 2010) and 1 other predicate after a 119-day review. Its family tree reaches back 8 generations to 1995. 1 of the 27 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Jun 1, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954234 (1995). 18 ancestors in all, the oldest K862691 (1986). 8 later devices descend from it, 1 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 7 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 6 generations backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- 5 generations backK032569 Short Introducer SheathRex Medical · 2003
- 4 generations backK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- 3 generations backK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- 2 generations backK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- 1 generation backK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- This deviceK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
- Descendant · cites it directly · 7 of its ownK141617 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
- Descendant · 2 generations on · 5 of its ownK211798 Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK223891 Cobra Catheter SystemEndovascular Engineering · 2023
- Descendant · 4 generations on · 1 of its ownK252956 Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK261800 Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K011056 Arrow-Trerotola Percutaneous Thrombolytic Device…2 generations back · 2001
Most influential descendants
Showing 5 of 8 · See all- K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014 · cites it directly7descendants
- K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022 · 2 generations on5descendants
- K223891Cobra Catheter SystemEndovascular Engineering · 2023 · 3 generations on2descendants
- K252956Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025 · 4 generations on1descendant
- K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −7 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −6 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| −5 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| −4 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| −3 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| −2 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| −1 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| 0 (this device) | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
| +1 | K141617 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2014 | — |
| +2 | K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | 2022 | — |
| +3 | K223891 | Cobra Catheter System | Endovascular Engineering | 2023 | — |
| +4 | K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025 | — |
| +5 | K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 1 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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.
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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Summary page 1…Cleaner TmRotational Thrombectomy System Common Name: Peripheral Atherectomy Catheter (21 CER 870.4875, Product Code MCW) Predicate Device(s): K091029 Cleaner TM Rotational Thrombectomy System K060904 CleanerTM Rotational Thrombectomy System Device Desc… | 2010 |
| * | K060904 | Cleaner Rotational Thrombectomy SystemSummary page 1…me: Peripheral Atherectomy Catheter (21 CER 870.4875, Product Code MCW) Predicate Device(s): K091029 Cleaner TM Rotational Thrombectomy System K060904 CleanerTM Rotational Thrombectomy System Device Description The Cleanerm Rotational Thrombectomy System is a 7F per… | 2006 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141617 | Cleaner Rotational Thrombectomy System | 2014 | 7 |
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 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141617 (Rex Medical, L.P., 2014) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K091029.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cleaner Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120346: Cleaner Rotational 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/K120346
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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