FDA applicant

Diatek, Inc.

Mchenry, IL15 decisions1979–20024 recalls

FDA records 15 decisions for Diatek, Inc. (Mchenry, IL) from 1979 to 2002: 15 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 1 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Diatek, Inc. since 2007.

Recalls per year

2in 2020

2007high 2 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Diatek”

FDA records each applicant name separately; these may or may not be the same firm.

Diatek Instruments, Inc. 1

Diatek, 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?

Other applicant names beginning “Diatek”