510(k) · Cleared
ClearedCleaner II 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 Dec 16, 2003 as substantially equivalent to K031610 (Rex Medical, 2003) and 4 other predicates after an 11-day review. Its family tree reaches back 4 generations to 1995. 12 later devices descend from it.
- Decided
- Dec 16, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K954234 (1995). 13 ancestors in all, the oldest K862691 (1986). 12 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 3 generations backK984260 Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath &…Terumo Medical Corp. · 1999
- 2 generations backK022170 Inner-Lock Locking Introducer SheathsRex Medical · 2003
- 1 generation backK032569 Short Introducer SheathRex Medical · 2003
- This deviceK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · cites it directly · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · 2 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- Descendant · 3 generations on · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- Descendant · 3 generations on · 8 of its ownK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
- Descendant · 4 generations on · 7 of its ownK141617 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · cites it directly11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 2 generations on10descendants
- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · 3 generations on9descendants
- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · 3 generations on8descendants
- K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −3 | K984260 | Pinnacle R/O or Redifocus Introducer R/O (Comprised of a Sheath & Dilator) | Terumo Medical Corp. | 1999 | — |
| −2 | K022170 | Inner-Lock Locking Introducer Sheaths | Rex Medical | 2003 | — |
| −1 | K032569 | Short Introducer Sheath | Rex Medical | 2003 | — |
| 0 (this device) | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +1 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +2 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| +3 | 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 | — |
| +4 | K141617 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2014 | — |
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 |
|---|---|---|
| 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? (5)
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…al Thrombectomy System". 3. Common or Usual Name: Intraluminal Artery Stripper (Peripheral Atherectomy Catheter) 4. Predicate Device Information: 1) K031610: CleanerTm Rotational Thrombectomy System 2) K902327: Embolectomy Catheter 3) K032393: Stopcock 4) K022170: Inn… | 2003 |
| * | K902327 | Embolectomy CatheterSummary page 1…Intraluminal Artery Stripper (Peripheral Atherectomy Catheter) 4. Predicate Device Information: 1) K031610: CleanerTm Rotational Thrombectomy System 2) K902327: Embolectomy Catheter 3) K032393: Stopcock 4) K022170: Inner-LockTM Sheath Introducer 5) K032569: Short Sheath… | 1991 |
| * | K032393 | Induction and Sampling Manifold (or Stopcock)Summary page 1…al Atherectomy Catheter) 4. Predicate Device Information: 1) K031610: CleanerTm Rotational Thrombectomy System 2) K902327: Embolectomy Catheter 3) K032393: Stopcock 4) K022170: Inner-LockTM Sheath Introducer 5) K032569: Short Sheath Introducer… | 2003 |
| * | K022170 | Inner-Lock Locking Introducer SheathsSummary page 1…. Predicate Device Information: 1) K031610: CleanerTm Rotational Thrombectomy System 2) K902327: Embolectomy Catheter 3) K032393: Stopcock 4) K022170: Inner-LockTM Sheath Introducer 5) K032569: Short Sheath Introducer… | 2003 |
| * | K032569 | Short Introducer SheathSummary page 1…610: CleanerTm Rotational Thrombectomy System 2) K902327: Embolectomy Catheter 3) K032393: Stopcock 4) K022170: Inner-LockTM Sheath Introducer 5) K032569: Short Sheath Introducer Page 1 of 3… | 2003 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040252 | Cleaner Rotational Thrombectomy System Kit | 2004 | 11 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K040252 (Rex Medical, 2004) has gone furthest, with 11 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 Cleaner II Rotational Thrombectomy System permits mechanical declotting and removal of thrombi and emboli in synthetic grafts. The Embolectomy balloon component, located on the Cleaner II Device, may be used for subsequent Embolectomy procedures to remove emboli and thrombi in the arterial system communicating with the synthetic dialysis graft
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033793: Cleaner II 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/K033793
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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