SIGMA Spectrum Infusion Pump with Master Drug Library— 510(k) K251640
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K251640 for SIGMA Spectrum Infusion Pump with Master Drug Library, Substantially Equivalent on 2025-07-28. Applicant: Baxter Healthcare Corporation.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Lake, IL, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.