KabiHelp® Uno; KabiHelp® Advance plus— 510(k) K251139
Substantially EquivalentFresenius Kabi AG
FDA 510(k) clearance K251139 for KabiHelp® Uno; KabiHelp® Advance plus, Substantially Equivalent on 2026-01-09. Applicant: Fresenius Kabi AG.
Clearance details
- Applicant
- Fresenius Kabi AG
- Product code
- Code KPE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bad Homburg, DE
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.