FDA applicant

Advanced Instrumentations, Inc.

Hialeah, FL16 decisions2009–20170 recalls

FDA records 16 decisions for Advanced Instrumentations, Inc. (Hialeah, FL) from 2009 to 2017: 16 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 18 predicates, 0 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

2in 2017

2009high 8 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Advanced Instrumentations, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Instrumentations, 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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Advanced Instrumentations, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?