510(k) Report

FDA applicant

Rozinn Electronics, Inc.

Glendale, NY6 decisions1990–20060 recalls

FDA records 6 decisions for Rozinn Electronics, Inc. (Glendale, NY) from 1990 to 2006: 6 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and DXH (Transmitters And Receivers…). Its devices cite 8 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Rozinn Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rozinn Electronics, 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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