FDA applicant
Hosuk Co., Ltd.
FDA records 2 decisions for Hosuk Co., Ltd. (Minneapolis, MN) from 2000 to 2002: 2 510(k) clearances. All are in product code FMF (Syringe, Piston). Its devices cite 2 predicates, 1 of them its own earlier devices. 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hosuk Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hosuk Co., Ltd. since 2007.
Recalls per year
10in 2009
2007high 10 (2009) · low 0 (2007)2026
Class I Class II/III not classified
Planning a device like Hosuk 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