510(k) Report

FDA applicant

Hemotech, Inc.

Englewood, CO1 decision1991–19910 recalls

FDA records 1 decision for Hemotech, Inc. (Englewood, CO) in 1991: 1 510(k) clearance. All are in product code JOX (Analyzer, Heparin, 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 Hemotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hemotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hemotech, Inc.’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?

  • JOXAnalyzer, Heparin, Automated1decision

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.

  • K911240Hepcon HMS with Body Surface Area CalculationHemotech, Inc. · 19911cites it

What has FDA decided for it lately?

  • K911240Hepcon HMS with Body Surface Area CalculationHemotech, Inc. · 1991

The one decision as Hemotech, Inc. →