510(k) Report

FDA applicant

Hemosphere, Inc.

Eden Prarie, MN3 decisions2009–20120 recalls

FDA records 3 decisions for Hemosphere, Inc. (Eden Prarie, MN) from 2009 to 2012: 3 510(k) clearances. All are in product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). Its devices cite 6 predicates, 3 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 Hemosphere, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2009: 12012: 2
2009high 2 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

Planning a device like Hemosphere, 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?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K091491Hero Vascular Access DeviceHemosphere, Inc. · 20093cite it
  • K120006Hero GraftHemosphere, Inc. · 20122cite it
  • K121532Hero GraftHemosphere, Inc. · 20121cites it

What has FDA decided for it lately?

  • K121532Hero GraftHemosphere, Inc. · 2012
  • K120006Hero GraftHemosphere, Inc. · 2012
  • K091491Hero Vascular Access DeviceHemosphere, Inc. · 2009

All 3 as Hemosphere, Inc. →