FDA applicant

Sanguina, Inc.

Peachtree Corners, GA2 decisions2017–20230 recalls

FDA records 2 decisions for Sanguina, Inc. (Peachtree Corners, GA) from 2017 to 2023: 2 510(k) clearances. All are in product code KHG (Whole Blood Hemoglobin Determination). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

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

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

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

FDA decisions per year

1in 2023

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Sanguina, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sanguina, Inc.’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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Sanguina, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?