510(k) · Cleared
ClearedHelo Max Thrombectomy System (HEL2090)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endovascular Engineering · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Sep 3, 2026 as substantially equivalent to K252956 (Endovascular Engineering, Inc., 2025) after a 94-day review. Its family tree reaches back 19 generations to 1990. 1 of the 84 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 3, 2026
- Review
- 94 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K901627 (1990). 83 ancestors in all, the oldest K780551 (1978). No later device cites it as a predicate yet. 1 of the 84 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 15 generations between
- 3 generations backK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 2 generations backK223891 Cobra Catheter SystemEndovascular Engineering · 2023
- 1 generation backK252956 Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025
- This deviceK261800 Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
Show all 19 generations
- Root · 19 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 18 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 17 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 16 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 15 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 14 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 13 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 12 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 11 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 10 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 9 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 8 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 7 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 6 generations backK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
- 5 generations backK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- 4 generations backK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 3 generations backK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- 2 generations backK223891 Cobra Catheter SystemEndovascular Engineering · 2023
- 1 generation backK252956 Helo Thrombectomy SystemEndovascular Engineering, Inc. · 2025
- This deviceK261800 Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
Class I recalls in this family
- K011056 Arrow-Trerotola Percutaneous Thrombolytic Device…6 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −18 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −17 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −16 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −15 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −14 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −13 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −12 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −11 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −10 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −9 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −8 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| −7 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| −6 | K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020 | — |
| −5 | K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | 2021 | — |
| −4 | K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| −3 | K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| −2 | K223891 | Cobra Catheter System | Endovascular Engineering | 2023 | — |
| −1 | K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025 | — |
| 0 (this device) | K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 1 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K252956 | Helo Thrombectomy SystemSummary page 5…mary), KRA III. PREDICATE DEVICE Primary Predicate Device: Endovascular Engineering Helo Thrombectomy System (K252956) Reference Predicate Inari/Stryker FlowTriever Retrieval/Aspiratio… | 2025 |
| † | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K011056Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 83 ancestors have a recall of any class; 1 has a Class I recall.
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. 2026, 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 Hélo Max Thrombectomy System is indicated for:
The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature.
The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.
The Hēlo Max Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.
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/K261800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261800: Helo Max Thrombectomy System (HEL2090).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261800
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026