FDA applicant
Quantum Co., Ltd.
FDA records 3 decisions for Quantum Co., Ltd. (Shandong, CN) from 2009 to 2013: 3 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LFD (Saliva, Artificial). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Quantum, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Quantum Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Quantum 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) ReportOther applicant names beginning “Quantum”
FDA records each applicant name separately; these may or may not be the same firm.