510(k) Report

FDA applicant

Nexgen Medical Systems, Inc.

Melbourne, FL4 decisions2009–20110 recalls

FDA records 4 decisions for Nexgen Medical Systems, Inc. (Melbourne, FL) from 2009 to 2011: 4 510(k) clearances. Most are in product codes QEZ (Aspiration Thrombectomy Catheter) and DYB (Introducer, Catheter). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Nexgen Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2009: 12011: 3
2009high 3 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Nexgen Medical Systems, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nexgen Medical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QEZAspiration Thrombectomy Catheter1decision
  • DYBIntroducer, Catheter1decision
  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision
  • DQYCatheter, Percutaneous1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 20111cites it
  • K090932Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM, Model MRD-2000Nexgen Medical Systems, Inc. · 20091cites it

What has FDA decided for it lately?

  • K102925Nexgen Expandable CatheterNexgen Medical Systems, Inc. · 2011
  • K110315Nexgen Peripheral Mechanical Retrieval DeviceNexgen Medical Systems, Inc. · 2011
  • K102979Nexgen Peripheral Guide CatheterNexgen Medical Systems, Inc. · 2011
  • K090932Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80 CM, Model MRD-2000Nexgen Medical Systems, Inc. · 2009

All 4 as Nexgen Medical Systems, Inc. →