FDA applicant

Reflectance Medical, Inc.

Westborough, MA5 decisions2012–20140 recalls

FDA records 5 decisions for Reflectance Medical, Inc. (Westborough, MA) from 2012 to 2014: 5 510(k) clearances. All are in product code MUD (Oximeter, Tissue Saturation). Its devices cite 16 predicates, 9 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 Reflectance Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2012high 2 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Reflectance Medical, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Reflectance Medical, 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?