FDA applicant
Privi Medical Pte, Ltd.
FDA records 1 decision for Privi Medical Pte, Ltd. (Singapore, SG) in 2018: 1 510(k) clearance. All are in product code LKX (Device, Thermal, Hemorrhoids). 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 Privi Medical Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2018high 1 (2018) · low 0 (2019)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Privi Medical Pte, Ltd.’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