510(k) Report

FDA applicant

Sauquoit Industries, Inc.

Scranton, PA1 decision1985–19850 recalls

FDA records 1 decision for Sauquoit Industries, Inc. (Scranton, PA) in 1985: 1 510(k) clearance. All are in product code HLZ (Electrode, Corneal). 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 Sauquoit Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sauquoit Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HLZElectrode, Corneal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K844409DTL ElectrodeSauquoit Industries, Inc. · 19851cites it

What has FDA decided for it lately?

  • K844409DTL ElectrodeSauquoit Industries, Inc. · 1985

The one decision as Sauquoit Industries, Inc. →