510(k) · Cleared
Recalled · Class II · 2024XTD Thrombectomy Catheter, XX CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xtrak Medical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jul 26, 2002 as substantially equivalent to K013473 (Xtrak Medical, Inc., 2002) after a 67-day review. Its family tree reaches back 3 generations to 1990. It has been recalled once.
- Decided
- Jul 26, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- QEW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901627 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 2 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 1 generation backK013473 XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control…Xtrak Medical, Inc. · 2002
- This deviceK021641 XTD Thrombectomy Catheter, XX CMXtrak Medical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −2 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −1 | K013473 | XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model… | Xtrak Medical, Inc. | 2002 | — |
| 0 (this device) | K021641 | XTD Thrombectomy Catheter, XX CM | Xtrak Medical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 QEW? 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K013473 | XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model #…Summary page 5…79 Tel: (603) 896-6416 Fax: (603) 893-7708 Contact: Gary Boseck, Ph.D. President Identification of Predicate or Legally Marketed Devices The XTD™ Thrombectomy System (K013473) manufactured by Xtrak Medical, Inc. Intended Use For breaking apart and removing thrombus from hemodialysis access grafts. Dev… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2024 | Class II | Z-2213-2024 | Under Investigation by firm | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
For breaking apart and removing thrombus from hemodialysis access graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021641: XTD Thrombectomy Catheter, XX CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021641
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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