Baxter SIGMA Spectrum Infusion Pump with Master Drug Library— 510(k) K230022
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K230022 for Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Substantially Equivalent on 2023-03-31. 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
- Round Lake, IL, US
Recent devices under product code FRN
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- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
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 K230022
K-number listed on FDA's recall record- Z-2096-2025 — Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Z-0776-2025 — Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
- Z-2581-2024 — Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
- Z-2530-2024 — Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
- Z-2103-2023 — SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230022.
Data sourced from openFDA. This site is unofficial and independent of the FDA.