FDA applicant
Calidad Solutions, Inc.
FDA records 1 decision for Calidad Solutions, Inc. (Kent, WA) in 2010: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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 Calidad Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2010high 1 (2010) · low 0 (2011)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Calidad Solutions, 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