FDA applicant

Eigen

Nevada City, CA18 decisions1988–20230 recalls

FDA records 18 decisions for Eigen (Nevada City, CA) from 1988 to 2023: 18 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 349 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eigen, LLC”.

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

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

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

FDA decisions per year

1in 2023

2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eigen’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Eigen”

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

Eigen Video 4

Eigen

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Eigen”