510(k) · Cleared
ClearedWOLF Thrombectomy™ SmartClaw Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devoro Medical, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Nov 10, 2022 as substantially equivalent to K210911 (Devoro Medical, Inc., 2021) after a 181-day review. Its family tree reaches back 7 generations to 1983. 3 of the 22 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 10, 2022
- Review
- 181 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K832023 (1983). 20 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK832023 Embolectomy CatheterBionomy, Inc. · 1983
- 6 generations backK961883 Versa-Cath Arterial CatheterIdeas For Medicine, Inc. · 1997
- 5 generations backK040010 Genesis Medical Interventional F.a.S.T. (Facilitated…Genesis Medical Interventional, Inc. · 2004
- 4 generations backK143563 Infusion Aspiration Catheter SystemInari Medical, Inc. · 2015
- 3 generations backK182835 WOLF Thrombectomy Device880 Medical, LLC · 2019
- 2 generations backK200101 WOLF Thrombectomy V SystemDevoro Medical, Inc. · 2020
- 1 generation backK210911 WOLF Thrombectomy System, 14FDevoro Medical, Inc. · 2021
- This deviceK221391 WOLF Thrombectomy™ SmartClaw CatheterDevoro Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK241207 SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™…Devoro Medical, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K241207SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter…Devoro Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K832023 | Embolectomy Catheter | Bionomy, Inc. | 1983 | — |
| −6 | K961883 | Versa-Cath Arterial Catheter | Ideas For Medicine, Inc. | 1997 | — |
| −5 | K040010 | Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction… | Genesis Medical Interventional, Inc. | 2004 | — |
| −4 | K143563 | Infusion Aspiration Catheter System | Inari Medical, Inc. | 2015 | — |
| −3 | K182835 | WOLF Thrombectomy Device | 880 Medical, LLC | 2019 | — |
| −2 | K200101 | WOLF Thrombectomy V System | Devoro Medical, Inc. | 2020 | — |
| −1 | K210911 | WOLF Thrombectomy System, 14F | Devoro Medical, Inc. | 2021 | — |
| 0 (this device) | K221391 | WOLF Thrombectomy™ SmartClaw Catheter | Devoro Medical, Inc. | 2022 | — |
| +1 | K241207 | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy… | Devoro Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 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 |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K210911 | WOLF Thrombectomy System, 14FSummary page 4…rimary Product Code QEW Subsequent Product KRA Code Classification Class II, 21 CFR Part 870.5150 Predicate Device WOLF Thrombectomy System, 14F (K210911), cleared October 19, 2021 Reference Device Fogarty Venous Thrombectomy Catheter, 510(k) unknown Device Description T… | 2021 |
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 |
|---|---|---|---|
| K241207 | SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter… | 2024 | 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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 39 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 20 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K241207 (Devoro Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
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. 2022, 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 WOLF Thrombectomy SmartClaw Catheter, in conjunction with the WOLF Thrombectomy Aspiration Sheath, 14F, is indicated for:
• the non-surgical removal of thrombi and emboli from arterial and venous blood vessels in the peripheral vasculature.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221391: WOLF Thrombectomy™ SmartClaw Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221391
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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