510(k) · Cleared
ClearedROVO Mechanical Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
2mg, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Mar 31, 2023 as substantially equivalent to K113757 (Control Medical Technology, LLC, 2012) and 3 other predicates after a 379-day review. Its family tree reaches back 14 generations to 1990. 3 of the 102 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Mar 31, 2023
- Review
- 379 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K901627 (1990). 100 ancestors in all, the oldest K780551 (1978). 1 later device descends from it, 1 citing it directly. 3 of the 102 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 10 generations between
- 3 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 2 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 1 generation backK202218 ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical…Boston Scientific Corporation · 2020
- This deviceK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 13 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 12 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 11 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 10 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 9 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 8 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 7 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 6 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 5 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 4 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 3 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 2 generations backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- 1 generation backK202218 ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical…Boston Scientific Corporation · 2020
- This deviceK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −13 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −12 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −11 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −10 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −9 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −8 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −7 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −6 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −5 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −4 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −3 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| −2 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| −1 | K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | Boston Scientific Corporation | 2020 | — |
| 0 (this device) | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +1 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 1 |
| 1998 | 10 | 1 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 1 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K113757 | Aspire Max Aspiration CatheterSummary page 4…0.5150: Embolectomy catheter Regulatory Class: Class II Product Code: QEW (a)(3). Primary Predicate Device: K113757 – Aspire MAX Aspiration Catheter Secondary Predicate Device: K202218 – Zelante DVT ClotHunter Helical Rotation Devi… | 2012 |
| * | K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceSummary page 4…Product Code: QEW (a)(3). Primary Predicate Device: K113757 – Aspire MAX Aspiration Catheter Secondary Predicate Device: K202218 – Zelante DVT ClotHunter Helical Rotation Device Reference Devices: K121051 and K132409 – Merit Medical Co… | 2020 |
| * | K121051 | Concierge Guiding CatheterSummary page 4…pire MAX Aspiration Catheter Secondary Predicate Device: K202218 – Zelante DVT ClotHunter Helical Rotation Device Reference Devices: K121051 and K132409 – Merit Medical Concierge Catheters (a)(4). Device Description The ROVO Mechanical Thrombectomy Device is ind… | 2012 |
| * | K132409 | Concierge Guiding CatheterSummary page 4…iration Catheter Secondary Predicate Device: K202218 – Zelante DVT ClotHunter Helical Rotation Device Reference Devices: K121051 and K132409 – Merit Medical Concierge Catheters (a)(4). Device Description The ROVO Mechanical Thrombectomy Device is indicated for t… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253730 | RoVo Mechanical Thrombectomy System | 2026 | 0 |
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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 20 of the 100 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K253730 (Verge Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K113757.
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. 2023, 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 ROVO Mechanical Thrombectomy Device is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220780: ROVO Mechanical Thrombectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220780
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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