510(k) Report

510(k) · Cleared

Cleared

Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems

K040010510(k) TraditionalCleared Jul 19, 2004196-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genesis Medical Interventional, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on Jul 19, 2004 as substantially equivalent to K974335 (J-Lloyd Medical, Inc., 1998) and 7 other predicates after a 196-day review. Its family tree reaches back 2 generations to 1983. 3 of the 66 devices in its family, counting itself, have a Class I recall. 51 later devices descend from it.

Decided
Jul 19, 2004
Review
196 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K832023 (1983). 14 ancestors in all. 51 later devices descend from it, 3 citing it directly. 3 of the 66 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor, 1 with a Class I recall12001: 1 other ancestor2000: 1 other ancestor1998: 4 other ancestors, 1 with a Class I recall11997: 1 other ancestor, 1 with a Class I recall11995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1991: 1 other ancestor2015: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2019: 5 descendants cleared2018: 8 descendants cleared2016: 1 descendant cleared2020: 8 descendants cleared2017: 2 descendants cleared2023: 3 descendants cleared2022: 4 descendants cleared2021: 4 descendants cleared2024: 3 descendants cleared2025: 4 descendants cleared2026: 3 descendants clearedK832023 · Embolectomy Catheter · Bionomy, Inc. · 1983K961883 · Versa-Cath Arterial Catheter · Ideas For Medicine, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors, 2 with a Class I recall22 generations back: 5 other ancestors, 1 with a Class I recall1 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 16 descendants4 generations forward: 12 descendants5 generations forward: 7 descendants6 generations forward: 4 descendants K961883 · Versa-Cath Arterial Catheter · Ideas For Medicine, Inc. · 1997K832023 · Embolectomy Catheter · Bionomy, Inc. · 19830+5
  1. Root · 2 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
  2. 1 generation backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
  3. This deviceK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
  4. Descendant · cites it directly · 35 of its ownK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
  5. Descendant · cites it directly · 7 of its ownK092623 F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
  6. Descendant · 2 generations on · 6 of its ownK163549 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017
  7. Descendant · 2 generations on · 6 of its ownK162970 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter…Inari Medical · 2016
  8. Descendant · 2 generations on · 6 of its ownK132281 ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc. · 2013

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12012: 12013: 12015: 22016: 12017: 22018: 82019: 52020: 82021: 42022: 42023: 32024: 32025: 42026: 3
2008high 8 (2018) · low 0 (2010)2026

Class I recalls in this family

  • K022145 Over the Wire Embolectomy Catheter, Model 2302direct predicate · 2003
  • K973465 Latis Graft Cleaning Catheterdirect predicate · 1998
  • K970762 Dual Lumen Embolectomy Catheter2 generations back · 1997

Most influential descendants

Showing 5 of 51 · See all
  • K143563Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015 · cites it directly35descendants
  • K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009 · cites it directly7descendants
  • K163549ClotTriever Thrombectomy SystemInari Medical, Inc. · 2017 · 2 generations on6descendants
  • K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical · 2016 · 2 generations on6descendants
  • K132281ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc. · 2013 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K832023Embolectomy CatheterBionomy, Inc.1983—
−1K961883Versa-Cath Arterial CatheterIdeas For Medicine, Inc.1997—
0 (this device)K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction…Genesis Medical Interventional, Inc.2004—
+1K143563Infusion Aspiration Catheter SystemInari Medical, Inc.2015—
+1K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc.2009—
+2K163549ClotTriever Thrombectomy SystemInari Medical, Inc.2017—
+2K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction…Inari Medical2016—
+2K132281ReVive PV (Peripheral Vasculature) Thrombectomy DeviceCodman & Shurtleff, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199310
199410
199510
199711
199841
200010
200110
200311

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201210
201310
201520
201610
201720
201880
201950
202080
202140
202240
202330
202430
202540
202630
FIG. 1 — Lineage of K040010, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K974335Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc.
Summary page 1
…Embolectomy Catheter IlL. Predicate Devices * Embolectomy Irrigation-Occlusion Balloon Catheter (EIOBC) manufactured by J- Lloyd Medical (K974335); * Over the Wire Embolectomy Catheter manufactured by LeMaitre Vascular (K022145); * Dual Lumen Gr…
J-Lloyd Medical, Inc.1998—
*K022145Over the Wire Embolectomy Catheter, Model 2302
Summary page 1
…oon Catheter (EIOBC) manufactured by J- Lloyd Medical (K974335); * Over the Wire Embolectomy Catheter manufactured by LeMaitre Vascular (K022145); * Dual Lumen Graft Cleaning Catheter manufactured by Applied Medical Resources (K973465); * MSD E…
LeMaitre Vascular, Inc.2003Class I
*K973465Latis Graft Cleaning Catheter
Summary page 1
…my Catheter manufactured by LeMaitre Vascular (K022145); * Dual Lumen Graft Cleaning Catheter manufactured by Applied Medical Resources (K973465); * MSD Embolectomy Basket manufactured by Metamorphic Surgical Devices (K991093); * Versa-Cath Art…
Applied Medical Resources1998Class I
*K991093MSD Embolectomy Basket
Summary page 1
…ing Catheter manufactured by Applied Medical Resources (K973465); * MSD Embolectomy Basket manufactured by Metamorphic Surgical Devices (K991093); * Versa-Cath Arterial Catheter manufactured by Ideas for Medicine (K961883); * Biosensors Embolectomy Cathete…
Metamorphic Surgical Devices, LLC2000—
*K961883Versa-Cath Arterial Catheter
Summary page 1
…* MSD Embolectomy Basket manufactured by Metamorphic Surgical Devices (K991093); * Versa-Cath Arterial Catheter manufactured by Ideas for Medicine (K961883); * Biosensors Embolectomy Catheter manufactured by Sunscope International (K973477); * Core and Co…
Ideas For Medicine, Inc.1997—
*K973477Biosensors Embolectomy Catheter
Summary page 1
…Versa-Cath Arterial Catheter manufactured by Ideas for Medicine (K961883); * Biosensors Embolectomy Catheter manufactured by Sunscope International (K973477); * Core and Coil Assembly (CCA) Guidewires manufactured by Lake Region Manufacturing (K971322); *…
Sunscope Intl., Inc.1998—
*K971322Core and Coil Assembly Guidewire
Summary page 1
…r manufactured by Sunscope International (K973477); * Core and Coil Assembly (CCA) Guidewires manufactured by Lake Region Manufacturing (K971322); * Mandrel Guidewire Assembly manufactured by Lake Region Manufacturing (KO1 1084). IV. Product Descr…
Lake Region Mfg., Inc.1998—
*K011084Mandrel Guidewire AssemblyLake Region Mfg., Inc.2001—

What descends from it? (51)

See all 51

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143563Infusion Aspiration Catheter SystemInari Medical, Inc.201535
K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc.20097
K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086

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 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
  • K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
  • 4 of the 14 ancestors have a recall of any class; 3 have a Class I recall.
  • Of its descendants, K143563 (Inari Medical, Inc., 2015) has gone furthest, with 35 descendants of its own.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEW

14in 2025

2008: 22009: 22012: 12013: 22014: 22015: 42016: 42017: 22018: 142019: 82020: 162021: 112022: 122023: 232024: 142025: 142026 (partial year): 10
2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2015: 88 days median2016: 63 days median2018: 61 days median2019: 51 days median2020: 105 days median2021: 60 days median2022: 140 days median2023: 102 days median2024: 65 days median2025: 58 days median2026 (partial year): 74 days median
2007high 140 (2022) · low 51 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEW

7in 2022

2022: 7, 7 Class I
2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2019: 332020: 1972021: 3222022: 1252023: 1652024: 1622025: 207
2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20092—00
20100—00
20110—00
20121—00
20132—00
20142—00
201548800
201646300
20172—00
2018146100
2019851033
2020161050197
202111600322
2022121407 (7)125
2023231020165
202414650162
202514580207
202610740—

What is it indicated for?

The Genesis Medical InterventionalTM F.A.S.T.TM (Facilitated Aspiration/ Suction Thrombectomy) System is indicated for:

The non-surgical removal of emboli and thrombi from blood vessels.

The non-surgical removal of thrombi from synthetic grafts.

Use in temporary blood vessel/graft occlusion.

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.

More from Genesis Medical Interventional, Inc.

2 FDA decisions under this applicant name. See the company

  • K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009

Recent decisions in QEW

The QEW category page

  • K262904INDIGO® Aspiration SystemPenumbra, Inc. · 2026
  • K253419Triever Duo CatheterInari Medical, Inc. · 2026
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
  • K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
  • K261523Vertex™ Thrombectomy SystemJupiter Endovascular · 2026

https://510kreport.com/device/K040010 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040010

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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