FDA applicant

Janssen Pharmaceutica NV

Beerse, BE2 decisions1985–20170 recalls

FDA records 2 decisions for Janssen Pharmaceutica NV (Beerse, BE) from 1985 to 2017: 2 510(k) clearances. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and FRN (Pump, Infusion). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Janssen Pharmaceutica, Inc.”.

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

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

How often FDA has decided Janssen Pharmaceutica NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Janssen Pharmaceutica NV’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 “Janssen”

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

Janssen Diagnostics 1 Janssen Research Foundation 1 Janssen Biochimica 1

Janssen Pharmaceutica NV

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Janssen”