510(k) Report

FDA applicant

Am2 Pat, Inc.

Raleigh, NC1 decision2003–20031 recall

FDA records 1 decision for Am2 Pat, Inc. (Raleigh, NC) in 2003: 1 510(k) clearance. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Am2 Pat, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Am2 Pat, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Am2 Pat, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Am2 Pat, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K032417Heparin Lock Flush SyringeAm2 Pat, Inc. · 20031 recall

The one decision as Am2 Pat, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K032417Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride…Dec 11, 2007