BMC Medical Co., Ltd.
FDA Regulatory Profile
BMC Medical Co., Ltd. has 1 FDA recall (1 Class I), 1 inspection, 7 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-2979-2026 · Class I · Jul 15, 2026
- Latest inspection
- Dec 1, 2014 · NAI
- Latest 510(k)
- Aug 14, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 (1 Class I) | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 7 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 1 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 1 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2979-2026 | Class I | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 | Jul 15, 2026 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Dec 1, 2014 | Beijing, China | Devices | No Action Indicated (NAI) | 3008566132 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | Aug 14, 2026 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | Apr 29, 2026 |
| K242935 | Respiration Data Management Software (PAP Link PC) | Jan 15, 2025 |
| K213169 | BPAP System | Dec 5, 2022 |
| K211155 | Auto CPAP System | Mar 9, 2022 |
| K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | Sep 5, 2017 |
| K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK | Apr 23, 2014 |