FDA applicant

Protocol Systems, Inc.

Beaverton, OR15 decisions1988–20000 recalls

FDA records 15 decisions for Protocol Systems, Inc. (Beaverton, OR) from 1988 to 2000: 15 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and DXN (System, Measurement, Blood-Pressure…). 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

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

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Protocol Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?