FDA applicant
Alicn Medical Shenzhen, Inc.
FDA records 13 decisions for Alicn Medical Shenzhen, Inc. (Shenzhen, CN) from 2018 to 2023: 13 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 289 days from receipt to decision, against 209 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Alicn Medical (Shenzhen), Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alicn Medical Shenzhen, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Alicn Medical Shenzhen, Inc.’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