510(k) Report

FDA applicant

Steripak, Ltd.

Northvale, NJ2 decisions1998–19980 recalls

FDA records 2 decisions for Steripak, Ltd. (Northvale, NJ) in 1998: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and FRO (Dressing, Wound, Drug). Its devices cite 2 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 Steripak, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Steripak, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Steripak, Ltd. 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)1decision
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K97218520 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd. · 19982cite it
  • K9808293ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution UspSteripak, Ltd. · 19981cites it

What has FDA decided for it lately?

  • K9808293ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution UspSteripak, Ltd. · 1998
  • K97218520 ML Normal Saline Topical Solution, 0.9% W/V Sodium ChlorideSteripak, Ltd. · 1998

All 2 as Steripak, Ltd. →