510(k) Report

FDA applicant

Colorado Medical, Inc.

Evergreen, CO6 decisions1983–19870 recalls

FDA records 6 decisions for Colorado Medical, Inc. (Evergreen, CO) from 1983 to 1987: 6 510(k) clearances. Most are in product codes LIF (Dialyzer Reprocessing System) and FIZ (Meter, Conductivity, Non-Remote). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Colorado Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Colorado Medical, 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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Other applicant names beginning “Colorado”

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