510(k) Report

FDA applicant

Optax Systems, Inc.

Hopkonton, MA1 decision2002–20020 recalls

FDA records 1 decision for Optax Systems, Inc. (Hopkonton, MA) in 2002: 1 510(k) clearance. All are in product code LQD (Recorder, Attention Task Performance). Its devices cite 1 predicate, 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

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

FDA decisions per year

No FDA decision for Optax Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optax Systems, 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?

  • LQDRecorder, Attention Task Performance1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K020800Optax SystemOptax Systems, Inc. · 20021cites it

What has FDA decided for it lately?

  • K020800Optax SystemOptax Systems, Inc. · 2002

The one decision as Optax Systems, Inc. →