FDA applicant

Mallinckrodt Sensor Systems, Inc.

Ann Arbor, MI2 decisions1991–19960 recalls

FDA records 2 decisions for Mallinckrodt Sensor Systems, Inc. (Ann Arbor, MI) from 1991 to 1996: 2 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). 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, clinical chemistry panel, where it files most

How often FDA has decided Mallinckrodt Sensor Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mallinckrodt Sensor Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mallinckrodt Sensor Systems, Inc.’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 Manufacturing, LLC 4 Mallinckrodt Medical Tpi, Inc. 4 Mallinckrodt Anesthesia Products 3 Mallinckrodt, Inc. 2 Mallinckrodt Dar S.R.L. 2

Mallinckrodt Sensor Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Mallinckrodt”