510(k) Report

FDA applicant

National Catheter Co. Div. Mallinckrodt

Mchenry, IL8 decisions1977–19810 recalls

FDA records 8 decisions for National Catheter Co. Div. Mallinckrodt (Mchenry, IL) from 1977 to 1981: 8 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and BTO (Tube, Tracheostomy (W/Wo Connector)). 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 National Catheter Co. Div. Mallinckrodt’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National Catheter Co. Div. Mallinckrodt since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like National Catheter Co. Div. Mallinckrodt’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