CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110— 510(k) K072885
Substantially EquivalentDraeger Medical AG & Co. KG
FDA 510(k) clearance K072885 for CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110, Substantially Equivalent on 2008-04-07. Applicant: Draeger Medical AG & Co. KG. Device class: 2.
Clearance details
- Applicant
- Draeger Medical AG & Co. KG
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Telford, PA, US
Recent devices under product code CBK
view allMore clearances from Draeger Medical AG & Co. KG
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K072885
K-number listed on FDA's recall record- Z-2248-2023 — Carina Sub-Acute Care Ventilator
- Z-1954-2018 — Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072885.
Data sourced from openFDA. This site is unofficial and independent of the FDA.