FDA applicant

Rota Systems,Inc.

Derby, KS1 decision1994–19940 recalls

FDA records 1 decision for Rota Systems,Inc. (Derby, KS) in 1994: 1 510(k) clearance. All are in product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Rota Systems,Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Rota”

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

Rota Systems Medfurniture, Inc. 2

Rota Systems,Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Rota”