510(k) Report

510(k) · Cleared

Cleared

Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM, Model MRD-2000

K090932510(k) TraditionalCleared Sep 24, 2009175-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nexgen Medical Systems, Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration

Cleared on Sep 24, 2009 after a 175-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Sep 24, 2009
Review
175 days
Class
Class II
Product code
QEW
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK090932 Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model…Nexgen Medical Systems, Inc. · 2009
  2. Descendant · cites it directly · 6 of its ownK110315 Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
  3. Descendant · 2 generations on · 5 of its ownK192814 Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020
  4. Descendant · 3 generations on · 4 of its ownK211492 Pounce Thrombectomy SystemSurmodics,Inc. · 2021
  5. Descendant · 4 generations on · 3 of its ownK220501 Pounce Thrombectomy SystemSurmodics,Inc. · 2022
  6. Descendant · 5 generations on · 2 of its ownK231022 Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12020: 12021: 12022: 12023: 12024: 12026: 1
2011high 1 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011 · cites it directly6descendants
  • K192814Pounce Thrombus Retrieval SystemSurmodics,Inc. · 2020 · 2 generations on5descendants
  • K211492Pounce Thrombectomy SystemSurmodics,Inc. · 2021 · 3 generations on4descendants
  • K220501Pounce Thrombectomy SystemSurmodics,Inc. · 2022 · 4 generations on3descendants
  • K231022Pounce™ Thrombectomy SystemSurmodics,Inc. · 2023 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090932Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM…Nexgen Medical Systems, Inc.2009—
+1K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc.2011—
+2K192814Pounce Thrombus Retrieval SystemSurmodics,Inc.2020—
+3K211492Pounce Thrombectomy SystemSurmodics,Inc.2021—
+4K220501Pounce Thrombectomy SystemSurmodics,Inc.2022—
+5K231022Pounce™ Thrombectomy SystemSurmodics,Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202010
202110
202210
202310
202410
202610
FIG. 1 — Lineage of K090932, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K213402 Triever24, Triever20score 28.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc.20116

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?

  • Of its descendants, K110315 (Nexgen Medical Systems, Inc., 2011) has gone furthest, with 6 descendants of its own.

How does its category compare?

All QEW devices

QEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · QEW

14in 2025

2008: 22009: 22012: 12013: 22014: 22015: 42016: 42017: 22018: 142019: 82020: 162021: 112022: 122023: 232024: 142025: 142026 (partial year): 10
2007high 23 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEW

58in 2025

2015: 88 days median2016: 63 days median2018: 61 days median2019: 51 days median2020: 105 days median2021: 60 days median2022: 140 days median2023: 102 days median2024: 65 days median2025: 58 days median2026 (partial year): 74 days median
2007high 140 (2022) · low 51 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEW

7in 2022

2022: 7, 7 Class I
2007high 7 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · QEW

207in 2025

2019: 332020: 1972021: 3222022: 1252023: 1652024: 1622025: 207
2007high 322 (2021) · low 0 (2007)2025

MAUDE reports naming product code QEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20092—00
20100—00
20110—00
20121—00
20132—00
20142—00
201548800
201646300
20172—00
2018146100
2019851033
2020161050197
202111600322
2022121407 (7)125
2023231020165
202414650162
202514580207
202610740—

What is it indicated for?

The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and 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 510(k) statement.

More from Nexgen Medical Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K102925Nexgen Expandable CatheterNexgen Medical Systems, Inc. · 2011
  • K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
  • K102979Nexgen Peripheral Guide CatheterNexgen Medical Systems, Inc. · 2011

Recent decisions in QEW

The QEW category page

  • K262904INDIGO® Aspiration SystemPenumbra, Inc. · 2026
  • K253419Triever Duo CatheterInari Medical, Inc. · 2026
  • K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering · 2026
  • K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc. · 2026
  • K261523Vertex™ Thrombectomy SystemJupiter Endovascular · 2026

https://510kreport.com/device/K090932 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090932: Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM, Model MRD-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090932

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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