FDA applicant
Jelco Laboratories
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
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.
Planning a device like Jelco Laboratories’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