510(k) Report

FDA applicant

Acu-Pak

Londonderry, NH1 decision1998–19980 recalls

FDA records 1 decision for Acu-Pak (Londonderry, NH) in 1998: 1 510(k) clearance. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). 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, general hospital panel, where it files most

How often FDA has decided Acu-Pak’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acu-Pak since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Acu-Pak 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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K981905Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO. 10291Acu-Pak · 1998

The one decision as Acu-Pak →