510(k) Report

FDA applicant

The RX Files Corp.

Crofton, MD1 decision2001–20010 recalls

FDA records 1 decision for The RX Files Corp. (Crofton, MD) in 2001: 1 510(k) clearance. All are in product code NDC (Calculator, Drug Dose). 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, anesthesiology panel, where it files most

How often FDA has decided The RX Files Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The RX Files Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The RX Files Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NDCCalculator, Drug Dose1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011571TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 20015cite it

What has FDA decided for it lately?

  • K011571TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001

The one decision as The RX Files Corp. →