510(k) Report

FDA applicant

Individual Monitoring Systems, Inc.

Baltimore, MD2 decisions1999–20010 recalls

FDA records 2 decisions for Individual Monitoring Systems, Inc. (Baltimore, MD) from 1999 to 2001: 2 510(k) clearances. All are in product code GWQ (Full-Montage Standard Electroencephalograph). Its devices cite 2 predicates, 1 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

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Individual Monitoring Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Individual Monitoring Systems, Inc.’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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Which product codes does it file in?

  • GWQFull-Montage Standard Electroencephalograph2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K992410ActitracIndividual Monitoring Systems, Inc. · 19995cite it

What has FDA decided for it lately?

  • K010997PAM-RLIndividual Monitoring Systems, Inc. · 2001
  • K992410ActitracIndividual Monitoring Systems, Inc. · 1999

All 2 as Individual Monitoring Systems, Inc. →