Spectrum IQ Infusion System with Dose IQ Safety Software— 510(k) K230041
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K230041 for Spectrum IQ Infusion System with Dose IQ Safety Software, 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
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)
- 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 K230041
K-number listed on FDA's recall record- Z-2415-2025 — Spectrum IQ Infusion Pump, Product Code 3570009
- Z-1254-2025 — Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Z-0348-2025 — Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Z-2582-2024 — Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
- Z-1810-2024 — Spectrum IQ Infusion pump, Product Code 357009
- Z-1775-2024 — Baxter Spectrum IQ Infusion Pump, Product Code 3570009
- Z-2104-2023 — The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230041.
Data sourced from openFDA. This site is unofficial and independent of the FDA.