FDA applicant
Walpak Co.
FDA records 11 decisions for Walpak Co. (Mchenry, IL) from 1976 to 1981: 11 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and KOD (Catheter, Urological). 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 Walpak Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Walpak Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Walpak Co.’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