510(k) Report

FDA applicant

Blairex Laboratories, Inc.

Columbus, IN3 decisions1983–20080 recalls

FDA records 3 decisions for Blairex Laboratories, Inc. (Columbus, IN) from 1983 to 2008: 3 510(k) clearances. Most are in product codes HPX (Lens, Contact (Polymethylmethacrylate)) and FRO (Dressing, Wound, Drug). Its devices cite 6 predicates, 0 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

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

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Blairex Laboratories, 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?

  • HPXLens, Contact (Polymethylmethacrylate)2decisions
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 20084cite it

What has FDA decided for it lately?

  • K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 2008
  • K833903Benzethonium ChlorideBlairex Laboratories, Inc. · 1984
  • K832810Hard Contact Lens CleanerBlairex Laboratories, Inc. · 1983

All 3 as Blairex Laboratories, Inc. →