510(k) · Cleared
ClearedAngiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit
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 May 18, 2004 as substantially equivalent to K972610 (Possis Medical, Inc., 2000) and 4 other predicates after a 134-day review. Its family tree reaches back 3 generations to 1990. 4 of the 78 devices in its family, counting itself, have a Class I recall. 70 later devices descend from it.
- Decided
- May 18, 2004
- Review
- 134 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K901627 (1990). 7 ancestors in all, the oldest K780551 (1978). 70 later devices descend from it, 5 citing it directly. 4 of the 78 devices in this family, counting this one, have a Class I recall.
- 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 deviceK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- Descendant · cites it directly · 68 of its ownK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- Descendant · cites it directly · 66 of its ownK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- Descendant · cites it directly · 63 of its ownK071514 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- Descendant · cites it directly · 34 of its ownK050794 Angiojet DVX Rheolytic Thrombectomy CatheterPossis Medical, Inc. · 2005 · Recalled
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 70 · See all- K052256Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005 · cites it directly68descendants
- K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006 · cites it directly66descendants
- K071514Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007 · cites it directly63descendants
- K071342Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041…Possis Medical, Inc. · 2007 · 2 generations on34descendants
- K050794Angiojet DVX Rheolytic Thrombectomy CatheterPossis Medical, Inc. · 2005 · cites it directly34descendants
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) | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| +1 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| +1 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| +1 | K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | Possis Medical, Inc. | 2007 | — |
| +2 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| +1 | K050794 | Angiojet DVX Rheolytic Thrombectomy Catheter | Possis Medical, Inc. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 1 |
| 2020 | 2 | 0 |
| 2021 | 6 | 1 |
| 2022 | 2 | 0 |
| 2023 | 9 | 1 |
| 2024 | 3 | 0 |
| 2025 | 5 | 1 |
| 2026 | 3 | 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.
4 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter…Summary page 5…ary Kit product code is 74 KRA. Predicate Device(s): The AngioJet 120 Catheter is substantially equivalent to the devices listed below: e The AngioJet LF140 Catheter (K972610) e The AngioJet Xpeedior 60 Catheter (K993564). The AngioJet Power Pulse Spray Ancillary Kit is substantially equivalent to: e… | 2000 |
| * | K993564 | Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002Summary page 5…ice(s): The AngioJet 120 Catheter is substantially equivalent to the devices listed below: e The AngioJet LF140 Catheter (K972610) e The AngioJet Xpeedior 60 Catheter (K993564). The AngioJet Power Pulse Spray Ancillary Kit is substantially equivalent to: e AngioDynamics Power Pulsed Spray Infusion Syst… | 2000 |
| * | K905447 | E-Z-EM Pulsed Infusion SystemSummary page 5…gioJet Xpeedior 60 Catheter (K993564). The AngioJet Power Pulse Spray Ancillary Kit is substantially equivalent to: e AngioDynamics Power Pulsed Spray Infusion System (K905447 and K951509) ¢ B.Braun Universal Spike Adaptor Y-Set (K780551). Device Description: The AngioJet Xpeedior 120 Catheter is a si… | 1991 |
| * | K951509 | Pulse*Spray Infusion SystemSummary page 5…ior 60 Catheter (K993564). The AngioJet Power Pulse Spray Ancillary Kit is substantially equivalent to: e AngioDynamics Power Pulsed Spray Infusion System (K905447 and K951509) ¢ B.Braun Universal Spike Adaptor Y-Set (K780551). Device Description: The AngioJet Xpeedior 120 Catheter is a single-use com… | 1995 |
| * | K780551 | I.V. Administration Set with Mini-SpikeSummary page 5…e Spray Ancillary Kit is substantially equivalent to: e AngioDynamics Power Pulsed Spray Infusion System (K905447 and K951509) ¢ B.Braun Universal Spike Adaptor Y-Set (K780551). Device Description: The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy Syste… | 1978 |
What descends from it? (70)
See all 705 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052256 | Angiojet Xpeedior 120 Catheter | 2005 | 68 |
| K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | 2006 | 66 |
| K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | 2007 | 63 |
| K050794 | Angiojet DVX Rheolytic Thrombectomy Catheter | 2005 | 34 |
| K071336 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | 2007 | 33 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K223210ClotTriever XL CatheterInari Medical, Inc. · 2023 · 10 generations on · ◆ in the 2023 descendants bar of FIG. 11 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 4.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K052256 (Possis Medical, Inc., 2005) has gone furthest, with 68 descendants 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?
1. The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infrainguinal peripheral arteries >3.0 mm in diameter.
2. The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.
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/K040013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040013: Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040013
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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