FDA applicant
Instromedix, Inc.
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
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.
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.
See the 510(k) Report