510(k) Report

FDA applicant

Zeiss Humphrey System

San Leandro, CA9 decisions1979–19940 recalls

FDA records 9 decisions for Zeiss Humphrey System (San Leandro, CA) from 1979 to 1994: 9 510(k) clearances. Most are in product codes HPT (Perimeter, Automatic, Ac-Powered) and HKI (Camera, Ophthalmic, Ac-Powered). 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 Zeiss Humphrey System’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zeiss Humphrey System since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Zeiss”

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