510(k) Report

FDA applicant

Proton Healthcare, Ltd.

Littleton, CO2 decisions2005–20060 recalls

FDA records 2 decisions for Proton Healthcare, Ltd. (Littleton, CO) from 2005 to 2006: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). 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 Proton Healthcare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Proton Healthcare, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Proton”

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