FDA applicant
A&D Company, Ltd.
FDA records 10 decisions for A&D Company, Ltd. (San Jose, CA) from 2011 to 2022: 10 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 362 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “A & D Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided A&D Company, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like A&D Company, 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