FDA applicant

Mckinley Medical, LLC

Wheat Ridge, CO2 decisions2005–20060 recalls

FDA records 2 decisions for Mckinley Medical, LLC (Wheat Ridge, CO) from 2005 to 2006: 2 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and MEB (Pump, Infusion, Elastomeric). Its devices cite 5 predicates, 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Mckinley Medical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mckinley Medical, LLC’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 “Mckinley”

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

Mckinley, Inc. 7 Mckinley-Ross Laboratories, Inc. 1 Mckinley Infuser 1

Mckinley Medical, LLC

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?

Other applicant names beginning “Mckinley”