510(k) Report

FDA applicant

Pharma-Pen, Inc.

Washington, DC1 decision2006–20060 recalls

FDA records 1 decision for Pharma-Pen, Inc. (Washington, DC) in 2006: 1 510(k) clearance. All are in product code KZH (Introducer, Syringe Needle). Its devices cite 3 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 Pharma-Pen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pharma-Pen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • KZHIntroducer, Syringe Needle1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K060389Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006

The one decision as Pharma-Pen, Inc. →