FDA applicant
A Plus International, Inc.
FDA records 11 decisions for A Plus International, Inc. (La Puente, CA) from 1988 to 2022: 11 510(k) clearances. Most are in product codes FYF (Cap, Surgical) and KKX (Drape, Surgical, Antimicrobial). 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 A Plus International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2007high 1 (2009) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like A Plus International, 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