510(k) · Cleared
Recalled · 2006X-Sizer Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3 Corporation · MCW Catheter, Peripheral, Atherectomy
Cleared on Sep 8, 2004 as substantially equivalent to K993816 (Baxter Edwards, 2000) and 2 other predicates after an 888-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 8, 2004
- Review
- 888 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K901627 (1990). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 1 generation backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- This deviceK021096 X-Sizer Catheter SystemEv3 Corporation · 2004
- Descendant · cites it directly · 3 of its ownK120508 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK140296 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014
- Descendant · 3 generations on · 1 of its ownK161786 ClearLumen II Thrombectomy SystemWalk Vascular, LLC · 2016
- Descendant · cites it directly · 1 of its ownK060016 Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2006 · Recalled
- Descendant · 4 generations on · 0 of its ownK163051 ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012 · cites it directly3descendants
- K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014 · 2 generations on2descendants
- K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC · 2016 · 3 generations on1descendant
- K060016Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2006 · cites it directly1descendant
- K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −1 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| 0 (this device) | K021096 | X-Sizer Catheter System | Ev3 Corporation | 2004 | — |
| +1 | K120508 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2012 | — |
| +2 | K140296 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2014 | — |
| +3 | K161786 | ClearLumen II Thrombectomy System | Walk Vascular, LLC | 2016 | — |
| +1 | K060016 | Thromcat Thrombectomy Catheter System | Kensey Nash Corp. | 2006 | 2 |
| +4 | K163051 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K993816 | Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FDSummary page 1…1 CFR Part 870.4875) Legally marketed devices to which ev3 Inc. claims substantial equivalence: Edwards Lifesciences Thrombex PMB~m System 5 10(k) No. K993 816 Solera Bacchus Thrombectomy Catheter (BTC) 510(k) No. K003 570 Possis AngioJet® LF140 Catheter… | 2000 |
| * | K003570 | Bacchus Thrombectomy Catheter (BTC), Model BTC-0755Summary page 1…l equivalence: Edwards Lifesciences Thrombex PMB~m System 5 10(k) No. K993 816 Solera Bacchus Thrombectomy Catheter (BTC) 510(k) No. K003 570 Possis AngioJet® LF140 Catheter 5 10(k) No. K960970 Description of the device that is the subject o… | 2001 |
| * | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…Summary page 1…k) No. K993 816 Solera Bacchus Thrombectomy Catheter (BTC) 510(k) No. K003 570 Possis AngioJet® LF140 Catheter 5 10(k) No. K960970 Description of the device that is the subject of this Premarket Notification: The X-SLZER System is a single-use, disposable med… | 1996 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2006 | Not classified | Z-1108-06 | Other | Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This… |
| Feb 14, 2006 | Not classified | Z-1107-06 | Other | Loss of Operating Vacuum during use-It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K120508 (Walk Vascular, LLC, 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K993816.
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 X-SIZER Catheter System is indicated for the mechanical removal of thrombus in
synthetic hemodialysis grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021096: X-Sizer Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021096
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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