510(k) Report

FDA applicant

R D Intl.

Richardson, TX2 decisions1996–19960 recalls

FDA records 2 decisions for R D Intl. (Richardson, TX) in 1996: 2 510(k) clearances. Most are in product codes DWP (Dilator, Vessel, Surgical) and MJJ (Cpb Check Valve, Retrograde Flow, In-Line). Its devices cite 1 predicate, 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, cardiovascular panel, where it files most

How often FDA has decided R D Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R D Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R D Intl. 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?

  • DWPDilator, Vessel, Surgical1decision
  • MJJCpb Check Valve, Retrograde Flow, In-Line1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K960937Suction Safety DeviceR D Intl. · 1996
  • K960312Rdi Cardiac Insulation PadR D Intl. · 1996

All 2 as R D Intl. →