FDA applicant
Healthstats International Pte., Ltd.
FDA records 7 decisions for Healthstats International Pte., Ltd. (Egale, WI) from 2005 to 2018: 7 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 18 predicates, 8 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 Healthstats International Pte., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Healthstats International 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