FDA applicant

Amuchina Intl., Inc.

Silver Spring, MD5 decisions1986–20000 recalls

FDA records 5 decisions for Amuchina Intl., Inc. (Silver Spring, MD) from 1986 to 2000: 5 510(k) clearances. Most are in product codes FKQ (System, Dialysate Delivery, Central Multiple…) and FKX (System, Peritoneal, Automatic Delivery). 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 Amuchina Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amuchina Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amuchina Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Amuchina Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?