510(k) · Cleared
Recalled · 2004Rex Medical Cleaner 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 May 27, 2003 as substantially equivalent to K990829 (Arrow Intl., Inc., 1999) and 2 other predicates after a 5-day review. Its family tree reaches back 1 generation to 1997. 13 later devices descend from it. It has been recalled once.
- Decided
- May 27, 2003
- Review
- 5 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K970080 (1997). 3 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970080 Arrow-Trerotola PTD CatheterArrow Intl., Inc. · 1997
- This deviceK031610 Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · cites it directly · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · cites it directly · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · cites it directly · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- Descendant · 2 generations on · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- Descendant · 2 generations on · 8 of its ownK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · cites it directly12descendants
- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · cites it directly11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · cites it directly10descendants
- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · 2 generations on9descendants
- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970080 | Arrow-Trerotola PTD Catheter | Arrow Intl., Inc. | 1997 | — |
| 0 (this device) | K031610 | Rex Medical Cleaner Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +1 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +1 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +1 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| +2 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| +2 | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K990829 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit…Summary page 1…epared: April 14,2003 2. Name of the Device: Rex Medical Cleaner" Rotational Thrombectomy System". 3. Predicate Device Information: 1. K#990829, Arrow-TrerotolaTMPTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA K#970080, Arrow-Trerotol… | 1999 |
| * | K970080 | Arrow-Trerotola PTD CatheterSummary page 1…em". 3. Predicate Device Information: 1. K#990829, Arrow-TrerotolaTMPTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA K#970080, Arrow-TrerotolaTMPTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA 2. K#003570, Sol… | 1997 |
| * | K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Summary page 1…International, Inc., Reading, PA K#970080, Arrow-TrerotolaTMPTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA 2. K#003570, SoleraTMBacchusTMThrombectomy Catheter (BTC), Bacchus Vascular, Inc. Santa Clara, CA 4. Device Description:… | 2001 |
What descends from it? (13)
See all 133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2004 | Not classified | Z-1315-04 | Other | The motor may fail to activate when the on/off switch is pressed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 device permits mechanical declotting in synthetic dialysis grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031610: Rex Medical 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/K031610
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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