510(k) Report

FDA applicant

Genesis Medical Interventional, Inc.

Redwood City, CA2 decisions2004–20090 recalls

FDA records 2 decisions for Genesis Medical Interventional, Inc. (Redwood City, CA) from 2004 to 2009: 2 510(k) clearances. All are in product code QEW (Peripheral Mechanical Thrombectomy With…). Its devices cite 9 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 Genesis Medical Interventional, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genesis Medical Interventional, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • QEWPeripheral Mechanical Thrombectomy With Aspiration2decisions

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) SystemsGenesis Medical Interventional, Inc. · 20043cite it
  • K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 20091cites it

What has FDA decided for it lately?

  • K092623F.a.S.T. System Sed and CXDGenesis Medical Interventional, Inc. · 2009
  • K040010Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) SystemsGenesis Medical Interventional, Inc. · 2004

All 2 as Genesis Medical Interventional, Inc. →

Other applicant names beginning “Genesis”

FDA records each applicant name separately; these may or may not be the same firm.

Genesis Industries, Inc. 17Genesis Fracture Care, Inc. 5Genesis Biosystems, Inc. 4Genesis Labs, Inc. 3Genesis Orthopedics, Inc. 2Genesis Digital Imaging, Inc. 2Genesis Software Innovations 2Genesis Medical, Inc. 2Genesis Medical Technology, Inc. 1Genesis Health Technologies 1Genesis Air, Inc. 1Genesis Health Light Corporation 1