510(k) Report

FDA applicant

Vision Biosystems, Inc.

Norwell, MA2 decisions2006–20070 recalls

FDA records 2 decisions for Vision Biosystems, Inc. (Norwell, MA) from 2006 to 2007: 2 510(k) clearances. Most are in product codes MYA (Immunohistochemistry Antibody Assay, Estrogen…) and MXZ (Immunohistochemistry Assay, Antibody…). 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, hematology panel, where it files most

How often FDA has decided Vision Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Vision Biosystems, 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?

  • MYAImmunohistochemistry Antibody Assay, Estrogen Receptor1decision
  • MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K060227Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Vision Biosystems, Inc. · 20061cites it

What has FDA decided for it lately?

  • K062615Vision Biosystems Progesterone Receptor PGR Clone 16Vision Biosystems, Inc. · 2007
  • K060227Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Vision Biosystems, Inc. · 2006

All 2 as Vision Biosystems, Inc. →