510(k) Report

FDA applicant

Primeline Industries, Inc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Primeline Industries, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code GAX (Tourniquet, Nonpneumatic). 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 and plastic surgery panel, where it files most

How often FDA has decided Primeline Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Primeline Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Primeline Industries, 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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Other applicant names beginning “Primeline”

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