510(k) Report

FDA applicant

Accufix Research Institute

Englewood, CO1 decision2000–20000 recalls

FDA records 1 decision for Accufix Research Institute (Englewood, CO) in 2000: 1 510(k) clearance. All are in product code DRB (Stylet, Catheter). 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 Accufix Research Institute’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Accufix Research Institute since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Accufix”

FDA records each applicant name separately; these may or may not be the same firm.