510(k) Report

FDA applicant

Massie Research Laboratories, Inc.

Dublin, CA2 decisions2000–20040 recalls

FDA records 2 decisions for Massie Research Laboratories, Inc. (Dublin, CA) from 2000 to 2004: 2 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and MXK (Device, Analysis, Anterior Segment). 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 Massie Research Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Massie Research Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Massie Research Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HKICamera, Ophthalmic, Ac-Powered1decision
  • MXKDevice, Analysis, Anterior Segment1decision

What has FDA decided for it lately?

  • K031788PathfinderMassie Research Laboratories, Inc. · 2004
  • K001275Retcam IIMassie Research Laboratories, Inc. · 2000

All 2 as Massie Research Laboratories, Inc. →