510(k) Report

FDA applicant

Pharmajet, Inc.

Golden, CO3 decisions2009–20110 recalls

FDA records 3 decisions for Pharmajet, Inc. (Golden, CO) from 2009 to 2011: 3 510(k) clearances. All are in product code KZE (Injector, Fluid, Non-Electrically Powered). Its devices cite 5 predicates, 2 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 Pharmajet, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2009: 12011: 2
2009high 2 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Pharmajet, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pharmajet, 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?

  • KZEInjector, Fluid, Non-Electrically Powered3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 20092cite it
  • K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 20111cites it

What has FDA decided for it lately?

  • K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis…Pharmajet, Inc. · 2011
  • K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
  • K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009

All 3 as Pharmajet, Inc. →