510(k) Report

FDA applicant

Vulcon Technologies

Grandview, MO1 decision1995–19950 recalls

FDA records 1 decision for Vulcon Technologies (Grandview, MO) in 1995: 1 510(k) clearance. All are in product code GKF (Instrument, Hematocrit, Automated). 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 Vulcon Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vulcon Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Vulcon Technologies’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?

  • GKFInstrument, Hematocrit, Automated1decision

What has FDA decided for it lately?

  • K953519Microspin 24Vulcon Technologies · 1995

The one decision as Vulcon Technologies →