FDA applicant

Micro Direct, Inc.

Auburn, ME9 decisions1994–20040 recalls

FDA records 9 decisions for Micro Direct, Inc. (Auburn, ME) from 1994 to 2004: 9 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and NRH (System, Breath Measurement). Its devices cite 5 predicates, 2 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

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Micro Direct, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Micro Direct, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?