FDA applicant
Stan-Pak Ent.
FDA records 20 decisions for Stan-Pak Ent. (Mchenry, IL) in 1982: 20 510(k) clearances. Most are in product codes NAB (Gauze / Sponge,Nonresorbable For External Use) and FQM (Bandage, Elastic). 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 Stan-Pak Ent.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Stan-Pak Ent. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Stan-Pak Ent.’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