Luebeck, DE · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CBK | — | — | — | 3 | 2026-05-07 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Class II | Anesthesiology | 1 | 2025-04-04 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Class II | Anesthesiology | 1 | 2023-06-14 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II | Anesthesiology | 1 | 2023-04-05 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-11-17 | Class II | Ongoing | Z-0971-2024 | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL) | — | Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while r… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-07 | K253647 | Evita (V800); Evita (V600) | CBK | — | — |
| 2025-04-04 | K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | BTL | Class II | Anesthesiology |
| 2023-06-14 | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | BZE | Class II | Anesthesiology |
| 2023-05-16 | K222207 | Babylog VN800, Babylog VN600 | CBK | — | — |
| 2023-05-16 | K222024 | Evita V800, Evita V600 | CBK | — | — |
| 2023-04-05 | K221118 | CO2 Mainstream Sensor | CCK | Class II | Anesthesiology |