510(k) · Cleared
ClearedNexgen Peripheral Mechanical Retrieval Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexgen Medical Systems, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Oct 20, 2011 as substantially equivalent to K090932 (Nexgen Medical Systems, Inc., 2009) and 2 other predicates after a 260-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 260 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970657 (1997). 6 ancestors in all, the oldest K892410 (1989). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970657 Lmi Thrombectomy CatheterLucas Medical, Inc. · 1997
- 1 generation backK070403 Pronto .035 Extraction CatheterVascular Solutions, Inc. · 2007
- This deviceK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK231022 Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK260599 INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192814Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020 · cites it directly5descendants
- K211492Pounce Thrombectomy SystemSurmodics,Inc. · 2021 · 2 generations on4descendants
- K220501Pounce Thrombectomy SystemSurmodics,Inc. · 2022 · 3 generations on3descendants
- K231022Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023 · 4 generations on2descendants
- K260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970657 | Lmi Thrombectomy Catheter | Lucas Medical, Inc. | 1997 | — |
| −1 | K070403 | Pronto .035 Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| 0 (this device) | K110315 | Nexgen Peripheral Mechanical Retrieval Device | Nexgen Medical Systems, Inc. | 2011 | — |
| +1 | K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020 | — |
| +2 | K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021 | — |
| +3 | K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022 | — |
| +4 | K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023 | — |
| +5 | K260599 | INDIGO® Aspiration System – INDIGO Link | Penumbra, Inc. | 2026 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 QEZ? 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 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 |
|---|---|---|---|
| * | K090932 | Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM, Model…Summary page 5…Classification Name Embolectomy Catheter Product Code: DXE Regulation: Class 11, 21 CFR 870.5150 Predicate Devices K090932 NexGen Medical Systems - Nex~en Peripheral Mechanical Retrieval Device (MRD)… | 2009 |
| * | K892410 | Fogarty (R) Thru-Lumen Embolectomy CatheterSummary page 5…Retrieval Device (MRD) 510(k) Unknown Edwards Lifesciences - Fogarty Venous Thrombectomy Catheter K892410 Edwards Lifesciences - Fogarty Thru Lumen Embolectomy Catheter K070403… | 1989 |
| * | K070403 | Pronto .035 Extraction CatheterSummary page 5…Catheter K892410 Edwards Lifesciences - Fogarty Thru Lumen Embolectomy Catheter K070403 Vascular Solutions - Pronto .035" extraction catheter Device Description The MRD is a member of a fa… | 2007 |
| * | — | Fogarty Venous Thrombectomy Catheter Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192814 | Pounce Thrombus Retrieval System | 2020 | 5 |
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 14 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K192814 (Surmodics,Inc., 2020) has gone furthest, with 5 descendants of its own.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The NexGen Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110315: Nexgen Peripheral Mechanical Retrieval Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110315
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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