FDA applicant

Mini-Mitter Co., Inc.

Sunriver, OR5 decisions1999–20043 recalls

FDA records 5 decisions for Mini-Mitter Co., Inc. (Sunriver, OR) from 1999 to 2004: 5 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GWK (Conditioner, Signal, Physiological). Its devices cite 4 predicates, 2 of them its own earlier devices. 3 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, neurology panel, where it files most

How often FDA has decided Mini-Mitter Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mini-Mitter Co., Inc. since 2007.

Recalls per year

3in 2007

2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Mini-Mitter Co., 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

Other applicant names beginning “Mini-Mitter”

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

Mini Lap Technologies, Inc. 5 Mini Floss 1

Mini-Mitter Co., 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?

What has been recalled?

Other applicant names beginning “Mini-Mitter”