Spectrum IQ Infusion System, Dose IQ Safety Software— 510(k) K173084
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K173084 for Spectrum IQ Infusion System, Dose IQ Safety Software, Substantially Equivalent on 2018-05-11. 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 K173084
K-number listed on FDA's recall record- Z-0529-2022 — Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
- Z-2165-2021 — Dose IQ Safety Software used with Spectrum IQ Infusion Pump
- Z-2110-2021 — Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
- Z-1487-2021 — Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
- Z-1150-2021 — Infusion Pump
- Z-0715-2021 — Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
- Z-0123-2021 — Spectrum IQ Infusion System with Dose IQ Safety Software
- Z-0107-2019 — SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.