FDA applicant
Paraworks Enterprise, Ltd.
FDA records 1 decision for Paraworks Enterprise, Ltd. (Vancouver, British Columbia, CA) in 1999: 1 510(k) clearance. All are in product code KMK (Device, Intravascular Catheter Securement). 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 Paraworks Enterprise, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Paraworks Enterprise, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Paraworks Enterprise, 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