FDA applicant
Qualiman Industrial Co., Ltd.
FDA records 1 decision for Qualiman Industrial Co., Ltd. (Greenwood Village, CO) in 2009: 1 510(k) clearance. All are in product code KKO (Ring, Teething, Fluid-Filled). 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 Qualiman Industrial Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2009high 1 (2009) · low 0 (2010)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Qualiman 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