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 Jul 30, 2021 as substantially equivalent to K192814 (Surmodics,Inc., 2020) after a 78-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 30, 2021
- Review
- 78 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970657 (1997). 8 ancestors in all, the oldest K892410 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK970657 Lmi Thrombectomy CatheterLucas Medical, Inc. · 1997
- 3 generations backK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
- 2 generations backK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
- 1 generation backK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
- This deviceK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
- Descendant · cites it directly · 3 of its ownK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK231022 Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK260599 INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241362 Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K220501Pounce Thrombectomy SystemSurmodics,Inc. · 2022 · cites it directly3descendants
- K231022Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023 · 2 generations on2descendants
- K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026 · 3 generations on0descendants
- K241362Pounce XL Thrombectomy System (PTS-1011-7F135)Surmodics,Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970657 | Lmi Thrombectomy Catheter | Lucas Medical, Inc. | 1997 | — |
| −3 | K070403 | Pronto .035 Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −2 | K110315 | Nexgen Peripheral Mechanical Retrieval Device | Nexgen Medical Systems, Inc. | 2011 | — |
| −1 | K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020 | — |
| 0 (this device) | K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021 | — |
| +1 | K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022 | — |
| +2 | K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023 | — |
| +3 | K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K192814 | Pounce Thrombus Retrieval SystemSummary page 4…Class II Product Code: QEW Review Panel: Cardiovascular PREDICATE [807.92(a)(3)] Predicate Device: Pounce™ Thrombectomy System (K192814) DEVICE DESCRIPTION [807.92(a)(4)] The Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mech… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220501 | Pounce Thrombectomy System | 2022 | 3 |
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 24 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K220501 (Surmodics,Inc., 2022) has gone furthest, with 3 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. 2021, 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.
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/K211492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211492: 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/K211492
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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