FDA applicant
BMC Medical Co., Ltd.
FDA records 7 decisions for BMC Medical Co., Ltd. (Beijing, CN) from 2014 to 2026: 7 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and MNS (Ventilator, Continuous, Non-Life-Supporting). Since 2016 its 510(k)s took a median of 215 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bmc Medical., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided BMC 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
No recall linked to its devices since 2014.
Planning a device like BMC 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