FDA applicant
Guangdong Biolight Meditech Co., Ltd.
FDA records 21 decisions for Guangdong Biolight Meditech Co., Ltd. (Shanghai, CN) from 2008 to 2019: 21 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 165 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 13 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 Guangdong Biolight Meditech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Guangdong Biolight Meditech 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) Report