510(k) Report

FDA applicant

Mallinckrodt Anesthesia Products

Argyle, NY3 decisions1989–19910 recalls

FDA records 3 decisions for Mallinckrodt Anesthesia Products (Argyle, NY) from 1989 to 1991: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and BYE (Attachment, Breathing, Positive End Expiratory…). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Mallinckrodt Anesthesia Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mallinckrodt”

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