510(k) · Cleared
ClearedF.a.S.T. System Sed and CXD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Medical Interventional, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Oct 30, 2009 as substantially equivalent to K040010 (Genesis Medical Interventional, Inc., 2004) after a 65-day review. Its family tree reaches back 3 generations to 1983. 3 of the 23 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Oct 30, 2009
- Review
- 65 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K832023 (1983). 15 ancestors in all. 7 later devices descend from it, 1 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 2 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 1 generation backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- This deviceK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK132281 ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK221204 Excipio SV Thrombectomy DeviceContego Medical, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK201085 NeVa PV Thrombectomy DeviceVesalio · 2021
- Descendant · 3 generations on · 1 of its ownK223897 Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK254211 pVasc Net Mechanical Thrombectomy DeviceVesalio, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K132281ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc. · 2013 · cites it directly6descendants
- K221204Excipio SV Thrombectomy DeviceContego Medical, Inc. · 2022 · 2 generations on2descendants
- K201085NeVa PV Thrombectomy DeviceVesalio · 2021 · 2 generations on2descendants
- K223897Excipio LV Thrombectomy DeviceContego Medical, Inc. · 2023 · 3 generations on1descendant
- K254211pVasc Net Mechanical Thrombectomy DeviceVesalio, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −2 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −1 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| 0 (this device) | K092623 | F.a.S.T. System Sed and CXD | Genesis Medical Interventional, Inc. | 2009 | — |
| +1 | K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | Codman & Shurtleff, Inc. | 2013 | — |
| +2 | K221204 | Excipio SV Thrombectomy Device | Contego Medical, Inc. | 2022 | — |
| +2 | K201085 | NeVa PV Thrombectomy Device | Vesalio | 2021 | — |
| +3 | K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc. | 2023 | — |
| +3 | K254211 | pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 4 | 1 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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.
3 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 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 |
|---|---|---|---|
| * | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy)…Summary page 5…Embolectomy Catheter Ill. Predicate Device Genesis Medical InterventionalTM F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System (K040010) IV. Product Description The F.A.S.T.TM System - SED (Self-Expanding Device) and F.A.S.T. TM System - CXD (Controlle… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | 2013 | 6 |
Has anything in its family been recalled? (3 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.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 4 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K132281 (Codman & Shurtleff, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K040010.
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. 2009, this device’s year, is highlighted.
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?
The F.A.S.T.TM System SED and CXD are indicated for:
The non-surgical removal of emboli and thrombi from blood vessels.
The non-surgical removal of thrombi from synthetic grafts.
Temporary use in vessel/graft occlusions.
Injection, infusion, and/or aspiration. of contrast media and other fluids into or from a vessel/graft.
Catheter placement over a guidewire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092623 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092623: F.a.S.T. System Sed and CXD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092623
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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