FDA applicant

Rotonics Mfg., Inc.

Bensenville, IL1 decision1998–19980 recalls

FDA records 1 decision for Rotonics Mfg., Inc. (Bensenville, IL) in 1998: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Rotonics Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Rotonics Mfg., Inc.

Which product codes does it file in?

What has FDA decided for it lately?