510(k) Report

FDA applicant

Holopack International, LP

Columbia, SC3 decisions1997–19980 recalls

FDA records 3 decisions for Holopack International, LP (Columbia, SC) from 1997 to 1998: 3 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). Its devices cite 7 predicates, 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, anesthesiology panel, where it files most

How often FDA has decided Holopack International, LP’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Holopack International, LP since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Holopack International, LP 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?

  • CAFNebulizer (Direct Patient Interface)3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K972466Sodium Chloride Inhalation Solution, UspHolopack International, LP · 19972cite it

What has FDA decided for it lately?

  • K9740560.9.% Sodium Chloride Inhalation Solution, UspHolopack International, LP · 1998
  • K972466Sodium Chloride Inhalation Solution, UspHolopack International, LP · 1997
  • K972467Sterile Water for Inhalation, UspHolopack International, LP · 1997

All 3 as Holopack International, LP →