510(k) Report

FDA applicant

Instromedix, Inc.

Hillsboro, OR33 decisions1977–20010 recalls

FDA records 33 decisions for Instromedix, Inc. (Hillsboro, OR) from 1977 to 2001: 33 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DTC (Analyzer, Pacemaker Generator Function). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Instromedix”.

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 Instromedix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instromedix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Instromedix, 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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