FDA applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
FDA records 6 decisions for Shinva Ande Healthcare Apparatus Co., Ltd. (Zibo, CN) from 2017 to 2022: 6 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and PNR (Enteral Syringes With Enteral Specific…). Since 2016 its 510(k)s took a median of 274 days from receipt to decision, against 216 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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 Shinva Ande Healthcare Apparatus Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Shinva Ande Healthcare Apparatus 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 “Shinva”
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