FDA applicant
Sejoy Electronics & Instruments Co., Ltd.
FDA records 14 decisions for Sejoy Electronics & Instruments Co., Ltd. (Hangzhou, Zhejiang, CN) from 2006 to 2017: 14 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 210 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 8 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 Sejoy Electronics & Instruments Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sejoy Electronics & Instruments Co.…’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 “Sejoy”
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