FDA applicant

Bioject, Inc.

Portland, OR9 decisions1987–20091 recall

FDA records 9 decisions for Bioject, Inc. (Portland, OR) from 1987 to 2009: 9 510(k) clearances. Most are in product codes KZE (Injector, Fluid, Non-Electrically Powered) and LHI (Set, I.V. Fluid Transfer). Its devices cite 7 predicates, 3 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 Bioject, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bioject, 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

Other applicant names beginning “Bioject”

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

Bioject Medical Technologies, Inc. 3

Bioject, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Bioject”