510(k) Report

FDA applicant

Bioject Medical Technologies, Inc.

Bedminster, NJ3 decisions2004–20120 recalls

FDA records 3 decisions for Bioject Medical Technologies, Inc. (Bedminster, NJ) from 2004 to 2012: 3 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and KZE (Injector, Fluid, Non-Electrically Powered). Its devices cite 6 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 Bioject Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioject Medical Technologies, Inc. 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?

  • LHISet, I.V. Fluid Transfer2decisions
  • KZEInjector, Fluid, Non-Electrically Powered1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K043304Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 20052cite it

What has FDA decided for it lately?

  • K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
  • K043304Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2005
  • K041564Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2004

All 3 as Bioject Medical Technologies, Inc. →

Other applicant names beginning “Bioject”

FDA records each applicant name separately; these may or may not be the same firm.

Bioject, Inc. 9