FDA applicant
Medionics International, Ltd.
FDA records 10 decisions for Medionics International, Ltd. (Markham, Ontario, CA) from 1982 to 2013: 10 510(k) clearances. Most are in product codes FKX (System, Peritoneal, Automatic Delivery) and KDJ (Set, Administration, For Peritoneal Dialysis…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medionics International, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medionics International, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medionics International, 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