FDA applicant
Maxstar Industrial Co., Ltd.
FDA records 3 decisions for Maxstar Industrial Co., Ltd. (Gimpo, KR) from 2014 to 2021: 3 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Its devices cite 3 predicates, 1 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 Maxstar Industrial Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Maxstar Industrial 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