510(k) Report

FDA applicant

Sharp Electronics Corp.

Paramus, NJ10 decisions1984–19880 recalls

FDA records 10 decisions for Sharp Electronics Corp. (Paramus, NJ) from 1984 to 1988: 10 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). 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 Sharp Electronics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sharp Electronics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sharp Electronics Corp.’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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Other applicant names beginning “Sharp”

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