FDA applicant
Csam, Inc.
FDA records 1 decision for Csam, Inc. (Bettendorf, IA) in 1999: 1 510(k) clearance. All are in product code FKP (System, Dialysate Delivery, Single Patient). 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 Csam, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Csam, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Csam, 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