FDA applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
FDA records 11 decisions for OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN) from 2020 to 2026: 10 510(k) clearances and 1 original PMA approval. Most are in product codes DQY (Catheter, Percutaneous) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 4 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 OrbusNeich Medical (Shenzhen) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like OrbusNeich Medical (Shenzhen) 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 “OrbusNeich”
FDA records each applicant name separately; these may or may not be the same firm.