FDA applicant
Foundations Plus, Inc.
FDA records 4 decisions for Foundations Plus, Inc. (Colleyville, TX) from 1986 to 1987: 4 510(k) clearances. All are in product code KGX (Tape And Bandage, Adhesive). 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 Foundations Plus, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Foundations Plus, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Foundations Plus, Inc.’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