Company ยท CN
BMC Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (2 in 12 months)
1recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2026 | K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) BMC Medical Co., Ltd., CN | CAW |
| Apr 29, 2026 | K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) BMC Medical Co., Ltd., CN | BZD |
| Jan 15, 2025 | K242935 | Respiration Data Management Software (PAP Link PC) BMC Medical Co., Ltd., CN | BZD |
| Dec 5, 2022 | K213169 | BPAP System BMC Medical Co., Ltd., CN | MNS |
| Mar 9, 2022 | K211155 | Auto CPAP System BMC Medical Co., Ltd., CN | BZD |
| Sep 5, 2017 | K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) Bmc Medical., Ltd., CN | BZD |
| Apr 23, 2014 | K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK BMC Medical Co., Ltd., CN | BZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2026 | BMC Medical Co., Ltd. BMC/REACTHEALTH
Luna G3 APAP
REF LG 3600 Open, Classified |
MNS | None listed |