FDA applicant
Km Products
FDA records 3 decisions for Km Products (Tucson, AZ) in 1985: 3 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and JOL (Catheter And Tip, Suction). 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 Km Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Km Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Km Products’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