FDA applicant
Andon Health Co, Ltd.
FDA records 92 decisions for Andon Health Co, Ltd. (Tianjin, CN) from 2008 to 2025: 92 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 157 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 106 predicates, 73 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 Andon Health Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Andon Health Co, 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) ReportOther applicant names beginning “Andon”
FDA records each applicant name separately; these may or may not be the same firm.