510(k) · Cleared
Recalled · 2007Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Possis Medical, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Nov 5, 2004 as substantially equivalent to K972610 (Possis Medical, Inc., 2000) after an 18-day review. Its family tree reaches back 3 generations to 1990. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 5, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901627 (1990). 3 later devices descend from it, 2 citing it directly.
- 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 backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- This deviceK042874 Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)Possis Medical, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK072769 Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553)…Possis Medical, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK113363 Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK080806 Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608Possis Medical, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K072769Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy SetsPossis Medical, Inc. · 2007 · cites it directly1descendant
- K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 2012 · 2 generations on0descendants
- K080806Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608Possis Medical, Inc. · 2008 · cites it directly0descendants
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 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| 0 (this device) | K042874 | Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX) | Possis Medical, Inc. | 2004 | — |
| +1 | K072769 | Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy… | Possis Medical, Inc. | 2007 | 1 |
| +2 | K113363 | Angiojet Solent Dista Thrombectomy Set | Medrad, Inc. | 2012 | 1 |
| +1 | K080806 | Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608 | Possis Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 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 |
|---|---|---|---|
| * | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter…Summary page 5…Rapid Exchange (XMI® - RX Classification 21 CFR 870.5150 Name and No. Embolectomy Catheter —Class 11 Product Code: DXE Predicate Device AngioJet LF140 Catheter under K972610 on 4/11/2000. Device Description: The AngioJet XMI Catheter — Rapid Exchange is a 135 cm, 4.0 French, sterile, single-use cathe… | 2000 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| May 1, 2007 | Not classified | Z-0955-2007 | Other | Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters. |
| Dec 12, 2005 | Not classified | Z-0469-06 | Other | It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K072769 (Possis Medical, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K972610.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The AngioJet XMI Catheter — Rapid Exchange is indicated for use with the AngioJet System in
breaking apart and removing thrombus from infra-inguinal peripheral arteries >2mm in diameter.
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/K042874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042874: Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042874
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