FDA applicant

Hemotec, Inc.

Englewood, CO15 decisions1980–19901 recall

FDA records 15 decisions for Hemotec, Inc. (Englewood, CO) from 1980 to 1990: 15 510(k) clearances. Most are in product codes JOX (Analyzer, Heparin, Automated) and JPA (System, Multipurpose For In Vitro Coagulation…). 1 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 Hemotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hemotec, Inc. since 2007.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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Hemotec, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?