FDA applicant
Kfx Medical
FDA records 7 decisions for Kfx Medical (Carlsbad, CA) from 2006 to 2012: 7 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 9 predicates, 3 of them its own earlier devices. 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 Kfx Medical’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2007high 2 (2008) · low 0 (2011)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kfx Medical’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