FDA applicant
Brosmed Medical Co., Ltd.
FDA records 10 decisions for Brosmed Medical Co., Ltd. (Dongguan, CN) from 2014 to 2025: 10 510(k) clearances. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 165 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Brosmed Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Brosmed Medical 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
1in 2018
Class I Class II/III not classified
Planning a device like Brosmed Medical 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