FDA applicant

Novo Nordisk, Inc.

Plainsboro, NJ14 decisions2005–20231 recall

FDA records 14 decisions for Novo Nordisk, Inc. (Plainsboro, NJ) from 2005 to 2023: 14 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 110 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 19 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 Novo Nordisk, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Novo Nordisk, Inc.’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 “Novo”

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

Novo Nordisk Diagnostics, Ltd. 2 Novo Diagnostic Systems 2 Novo Nordisk Pharmaceuticals, Inc. 2 Novo Norodisk Pharmaceuticals, Inc. 1 Novo Nordisk A/S 1

Novo Nordisk, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

What has been recalled?

Other applicant names beginning “Novo”