FDA applicant
Beijing Safe Heart Technology, Ltd.
FDA records 1 decision for Beijing Safe Heart Technology, Ltd. (Beijing Economic-Technological Developme, CN) in 2018: 1 510(k) clearance. All are in product code DQA (Oximeter). 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 Beijing Safe Heart Technology, 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 2018.
Planning a device like Beijing Safe Heart Technology, 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