FDA applicant

Infrascan, Inc.

Philadelphia, PA5 decisions2011–20240 recalls

FDA records 5 decisions for Infrascan, Inc. (Philadelphia, PA) from 2011 to 2024: 4 510(k) clearances and 1 De Novo grant. All are in product code OPT (Infrared Hematoma Detector). Its devices cite 5 predicates, 5 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2024

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Infrascan, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Infrascan, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?