FDA applicant

Irvine Biomedical,Inc.(Ibi)

Irvine, CA2 decisions2005–20074 recalls

FDA records 2 decisions for Irvine Biomedical,Inc.(Ibi) (Irvine, CA) from 2005 to 2007: 1 510(k) clearance and 1 original PMA approval. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and OAD (Catheter, Percutaneous, Cardiac Ablation, For…). Its devices cite 3 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Irvine Biomedical,Inc.(Ibi)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2009

2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Irvine Biomedical,Inc.(Ibi)’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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Other applicant names beginning “Irvine”

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

Irvine Scientific Sales Co., Inc. 40 Irvine Scientific 16 Irvine Biomedical, Inc. 13 Irvine Diagnostic Services 10 Irvine Biomedical, A St. Jude Medical Company 2

Irvine Biomedical,Inc.(Ibi)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Irvine”