FDA applicant

Hakki Medical Technologies, Inc.

Pinellas Park, FL2 decisions2011–20200 recalls

FDA records 2 decisions for Hakki Medical Technologies, Inc. (Pinellas Park, FL) from 2011 to 2020: 2 510(k) clearances. All are in product code GBM (Catheter, Urethral). Its devices cite 4 predicates, 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2020

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

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

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Hakki Medical Technologies, 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?