FDA applicant
Koag, LLC
FDA records 1 decision for Koag, LLC (Vonore, TN) in 2022: 1 510(k) clearance. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 1 predicate, 0 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 Koag, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2022high 1 (2022) · low 0 (2023)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Koag, LLC’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