510(k) Report

FDA applicant

Macosta Medical USA, LLC

Ayer, MA1 decision2004–20040 recalls

FDA records 1 decision for Macosta Medical USA, LLC (Ayer, MA) in 2004: 1 510(k) clearance. All are in product code CAZ (Anesthesia Conduction Kit). 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 Macosta Medical USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macosta Medical USA, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Macosta Medical USA, LLC 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?

  • CAZAnesthesia Conduction Kit1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K031128B-Smart, Model B-01Macosta Medical USA, LLC · 20041cites it

What has FDA decided for it lately?

  • K031128B-Smart, Model B-01Macosta Medical USA, LLC · 2004

The one decision as Macosta Medical USA, LLC →