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. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Lake, IL, US
Recent devices under product code FRN
view all- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
- K243855 — BD Alaris Infusion System with Guardrails Suite MX
More clearances from Baxter Healthcare Corporation
view all- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
- K242390 — Novum IQ Syringe Pump (40800BAXUS)
- K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
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 →
Recalls naming K251640
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251640.
Data sourced from openFDA. This site is unofficial and independent of the FDA.