510(k) · Cleared
ClearedCleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)
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 Feb 18, 2010 as substantially equivalent to K011056 (Arrow Intl., Inc., 2001) and 1 other predicate after a 314-day review. Its family tree reaches back 7 generations to 1995. 1 of the 27 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Feb 18, 2010
- Review
- 314 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954234 (1995). 17 ancestors in all, the oldest K862691 (1986). 9 later devices descend from it, 2 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 6 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 5 generations backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- 4 generations backK032569 Short Introducer SheathRex Medical · 2003
- 3 generations backK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- 2 generations backK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- 1 generation backK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- This deviceK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- Descendant · cites it directly · 8 of its ownK120346 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K011056 Arrow-Trerotola Percutaneous Thrombolytic Device…direct predicate · 2001
Most influential descendants
Showing 5 of 9 · See all- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · cites it directly8descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −6 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −5 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| −4 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| −3 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| −2 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| −1 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| 0 (this device) | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTDSummary page 1…System Common Name: Thrombectomy catheter Classification Name: Peripheral Atherectomny Catheter (21 CFR 870.4675, Product Code MOW) Predicate Device(s): K01 1056 Arrow-Trerotola TM Percutaneous Thrombolytic Device (PTD TM ) K060904 Cleaner T M Rotational Thr… | 2001 |
| * | K060904 | Cleaner Rotational Thrombectomy SystemSummary page 1…ral Atherectomny Catheter (21 CFR 870.4675, Product Code MOW) Predicate Device(s): K01 1056 Arrow-Trerotola TM Percutaneous Thrombolytic Device (PTD TM ) K060904 Cleaner T M Rotational Thrombectomy System Device Description: The Cleaner TM Rotational Thrombectomy System is… | 2006 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K120346 (Rex Medical, 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K011056.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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/K091029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091029: Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091029
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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