510(k) Report

FDA applicant

Jelco Laboratories

Mchenry, IL26 decisions1976–19790 recalls

FDA records 26 decisions for Jelco Laboratories (Mchenry, IL) from 1976 to 1979: 26 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and FPB (Filter, Infusion Line). 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 Jelco Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jelco Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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