510(k) · Cleared
ClearedPounce™ Thrombectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surmodics,Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Jun 12, 2023 as substantially equivalent to K220501 (Surmodics,Inc., 2022) after a 63-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 12, 2023
- Review
- 63 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970657 (1997). 10 ancestors in all, the oldest K892410 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK970657 Lmi Thrombectomy CatheterLucas Medical, Inc. · 1997
- 5 generations backK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
- 4 generations backK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
- 3 generations backK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
- 2 generations backK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
- 1 generation backK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
- This deviceK231022 Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260599 INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241362 Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970657 | Lmi Thrombectomy Catheter | Lucas Medical, Inc. | 1997 | — |
| −5 | K070403 | Pronto .035 Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −4 | K110315 | Nexgen Peripheral Mechanical Retrieval Device | Nexgen Medical Systems, Inc. | 2011 | — |
| −3 | K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020 | — |
| −2 | K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021 | — |
| −1 | K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022 | — |
| 0 (this device) | K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023 | — |
| +1 | K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | 2026 | — |
| +1 | K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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.
Planning a device in QEW? 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 |
|---|---|---|---|
| * | K220501 | Pounce Thrombectomy SystemSummary page 4…Cardiovascular Regulatory Class II Classification: Product Code: QEW Predicate Device: Pounce™ Thrombectomy System (K220501) K231022… | 2022 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K260599 (Penumbra, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K220501.
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 Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231022: Pounce™ Thrombectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231022
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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