FDA applicant

Mallinckrodt Manufacturing, LLC

Madison, WI4 decisions2020–20250 recalls

FDA records 4 decisions for Mallinckrodt Manufacturing, LLC (Madison, WI) from 2020 to 2025: 4 510(k) clearances. All are in product code MRN (Apparatus, Nitric Oxide Delivery). Since 2016 its 510(k)s took a median of 436 days from receipt to decision, against 566 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 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, anesthesiology panel, where it files most

How often FDA has decided Mallinckrodt Manufacturing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Mallinckrodt Manufacturing, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mallinckrodt Manufacturing, LLC’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 “Mallinckrodt”

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

Mallinckrodt Critical Care 92 Mallinckrodt Medical 43 Mallinckrodt Group, Inc. 27 Mallinckrodt Inc., Liebel-Flarsheim Business 8 Mallinckrodt Developpement France 7 Mallinckrodt Medical Tpi, Inc. 4 Mallinckrodt Anesthesia Products 3 Mallinckrodt, Inc. 2 Mallinckrodt Dar S.R.L. 2 Mallinckrodt Sensor Systems, Inc. 2

Mallinckrodt Manufacturing, LLC

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?

Other applicant names beginning “Mallinckrodt”