FDA applicant
Flume Catheter Company, Ltd.
FDA records 2 decisions for Flume Catheter Company, Ltd. (Farnham, GB) from 2021 to 2023: 2 510(k) clearances. All are in product code EZL (Catheter, Retention Type, Balloon). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “The Flume Catheter Company, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Flume Catheter Company, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Flume Catheter Company, Ltd.’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