FDA applicant

Spectralmd, Inc.

Dallas, TX3 decisions2013–20260 recalls

FDA records 3 decisions for Spectralmd, Inc. (Dallas, TX) from 2013 to 2026: 2 510(k) clearances and 1 De Novo grant. Most are in product codes DPT (Probe, Blood-Flow, Extravascular) and SHY (Software-Aided Adjunctive Diagnostic Device…). Its devices cite 5 predicates, 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2017

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Spectralmd, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Spectralmd, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?