Beijing, CN · 5 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | Anesthesiology | 3 | 2026-04-29 |
| CAW | Generator, Oxygen, Portable | Class II | Anesthesiology | 1 | 2026-08-14 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | Class II | Anesthesiology | 1 | 2022-12-05 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-07-15 | Class I | Ongoing | Z-2979-2026 | BMC/REACTHEALTH Luna G3 APAP REF LG 3600 | — | Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-14 | K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | CAW | Class II | Anesthesiology |
| 2026-04-29 | K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BZD | Class II | Anesthesiology |
| 2025-01-15 | K242935 | Respiration Data Management Software (PAP Link PC) | BZD | Class II | Anesthesiology |
| 2022-12-05 | K213169 | BPAP System | MNS | Class II | Anesthesiology |
| 2022-03-09 | K211155 | Auto CPAP System | BZD | Class II | Anesthesiology |