510(k) Report

FDA applicant

Halkey-Roberts Corp.

St. Petersburg, FL2 decisions2004–20060 recalls

FDA records 2 decisions for Halkey-Roberts Corp. (St. Petersburg, FL) from 2004 to 2006: 2 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FMG (Stopcock, I.V. Set). Its devices cite 4 predicates, 1 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 Halkey-Roberts Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Halkey-Roberts Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Halkey-Roberts 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?

  • LHISet, I.V. Fluid Transfer1decision
  • FMGStopcock, I.V. Set1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K040634Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp. · 20043cite it

What has FDA decided for it lately?

  • K061143Robertsite StopcockHalkey-Roberts Corp. · 2006
  • K040634Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp. · 2004

All 2 as Halkey-Roberts Corp. →