FDA applicant

Newport Bio Systems

Santa Ana, CA1 decision1985–19850 recalls

FDA records 1 decision for Newport Bio Systems (Santa Ana, CA) in 1985: 1 510(k) clearance. All are in product code KJA (Flask, Tissue Culture). 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, hematology panel, where it files most

How often FDA has decided Newport Bio Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Newport Bio Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Newport”

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

Newport Medical Instruments, Inc. 23 Newport Biosystems, Inc. 4

Newport Bio Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Newport”