510(k) Report

FDA applicant

Arlington Scientific, Inc. (Asi)

Springville, UT3 decisions2018–20200 recalls

FDA records 3 decisions for Arlington Scientific, Inc. (Asi) (Springville, UT) from 2018 to 2020: 3 510(k) clearances. All are in product code GMQ (Antigens, Nontreponemal, All). Its devices cite 3 predicates, 2 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, microbiology panel, where it files most

How often FDA has decided Arlington Scientific, Inc. (Asi)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 22020: 1
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Arlington Scientific, Inc. (Asi) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Arlington Scientific, Inc. (Asi)’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 “Arlington”

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