510(k) Report

FDA applicant

Rao Medical Devices, Inc.

Hudson, OH2 decisions1985–19860 recalls

FDA records 2 decisions for Rao Medical Devices, Inc. (Hudson, OH) from 1985 to 1986: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FKK (Clamp, Line). 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 Rao Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rao Medical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rao Medical Devices, Inc. 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?

  • FPASet, Administration, Intravascular1decision
  • FKKClamp, Line1decision

What has FDA decided for it lately?

  • K854965IN Line Valve Catalog NO. 2000ARao Medical Devices, Inc. · 1986
  • K854512Tubing Clamp Cat#1000-aRao Medical Devices, Inc. · 1985

All 2 as Rao Medical Devices, Inc. →