FDA applicant
Hsiner Co., Ltd.
FDA records 9 decisions for Hsiner Co., Ltd. (Temecula, CA) from 2005 to 2026: 9 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 25 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.
FDA’s records also spell it “Hsiner”, “Hsiner Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hsiner Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Hsiner 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) Report