FDA applicant
Ttk Healthcare Limited
FDA records 4 decisions for Ttk Healthcare Limited (Puducherry, IN) from 2001 to 2023: 4 510(k) clearances. Most are in product codes HIS (Condom) and KGO (Surgeon'S Gloves). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ttk Healthcare , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ttk Healthcare Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ttk Healthcare Limited’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