FDA applicant
Tri-State Hospital Supply Corp.
FDA records 16 decisions for Tri-State Hospital Supply Corp. (Howell, MI) from 1981 to 2008: 16 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and HFX (Clamp, Circumcision). Its devices cite 3 predicates, 1 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tri-State Hospital Supply Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2008
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Tri-State Hospital Supply Corp.’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