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, L.P. · MCW Catheter, Peripheral, Atherectomy
Cleared on Apr 28, 2006 as substantially equivalent to K031610 (Rex Medical, 2003) and 1 other predicate after a 25-day review. Its family tree reaches back 6 generations to 1995. 10 later devices descend from it.
- Decided
- Apr 28, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954234 (1995). 15 ancestors in all, the oldest K862691 (1986). 10 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 5 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 4 generations backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- 3 generations backK032569 Short Introducer SheathRex Medical · 2003
- 2 generations backK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- 1 generation backK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- This deviceK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- Descendant · cites it directly · 9 of its ownK091029 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 · 2 generations on · 7 of its ownK141617 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
- Descendant · 3 generations on · 5 of its ownK211798 Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK223891 Cobra Catheter SystemEndovascular Engineering · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · cites it directly9descendants
- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · cites it directly8descendants
- K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014 · 2 generations on7descendants
- K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022 · 3 generations on5descendants
- K223891Cobra Catheter SystemEndovascular Engineering · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −5 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −4 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| −3 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| −2 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| −1 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
| +2 | K141617 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2014 | — |
| +3 | K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | 2022 | — |
| +4 | K223891 | Cobra Catheter System | Endovascular Engineering | 2023 | — |
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 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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.
Planning a device in MCW? 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 |
|---|---|---|---|
| * | K031610 | Rex Medical Cleaner Rotational Thrombectomy SystemSummary page 1…Leedle Date Summary Prepared: February 9, 2006 2. Name of the Device: Cleaner~m Rotational Thrombectomy System 3. Predicate Device Information: K031 61 0, Cleanermh Rotational Thrombectomy System K040252, Cleaner~m Rotational Thrombectomy System Kit 4. Device Description:… | 2003 |
| * | K040252 | Cleaner Rotational Thrombectomy System KitSummary page 1…Name of the Device: Cleaner~m Rotational Thrombectomy System 3. Predicate Device Information: K031 61 0, Cleanermh Rotational Thrombectomy System K040252, Cleaner~m Rotational Thrombectomy System Kit 4. Device Description: The Rex Medical Cleaner~m Rotational Thrombectomy… | 2004 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K091029 (Rex Medical, 2010) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K031610.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Rex Medical CleanerTM Rotational Thrombectomy System is designed for
mechanical declotting of synthetic dialysis access grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060904 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060904: Cleaner Rotational Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060904
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