FDA applicant
Sunny Medical Device (Shenzhen) Co., Ltd.
FDA records 6 decisions for Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, CA) from 2012 to 2020: 6 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DXT (Injector And Syringe, Angiographic). Since 2016 its 510(k)s took a median of 288 days from receipt to decision, against 179 for FDA’s reviews in the same codes and years. Its devices cite 11 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 Sunny Medical Device (Shenzhen) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Sunny Medical Device (Shenzhen) 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 “Sunny”
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