510(k) Report

FDA applicant

North, Inc.

Northfield, MN2 decisions1995–19970 recalls

FDA records 2 decisions for North, Inc. (Northfield, MN) from 1995 to 1997: 2 510(k) clearances. Most are in product codes FMG (Stopcock, I.V. Set) and FMF (Syringe, Piston). 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 North, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like North, 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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