Atlas FDA

Spectrum IQ Infusion System with Dose IQ Safety Software

FDA 510(k) clearance K230041 · decided 2023-03-31

Clearance details

K-number
K230041
Device name
Spectrum IQ Infusion System with Dose IQ Safety Software
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2023-01-06
Decision date
2023-03-31
Days to decision
84 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Spectrum IQ Infusion Pump, Product Code 3570009 recall (Z-2415-2025)Baxter Healthcare Corporation2025-08-22
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 recall (Z-1254-2025)Baxter Healthcare Corporation2025-03-06
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 recall (Z-0348-2025)Baxter Healthcare Corporation2024-11-08
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the fol recall (Z-2582-2024)Baxter Healthcare Corporation2024-08-16
Spectrum IQ Infusion pump, Product Code 357009 recall (Z-1810-2024)Baxter Healthcare Corporation2024-05-13
Baxter Spectrum IQ Infusion Pump, Product Code 3570009 recall (Z-1775-2024)Baxter Healthcare Corporation2024-05-03
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 recall (Z-2104-2023)Baxter Healthcare Corporation2023-07-13

PMA approvals by this applicant

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PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
PerClot Polysaccharide Hemostatic System (P210036/S004)Baxter Healthcare Corporation2024-07-18
Seprafilm Adhesion Barrier (P950034/S058)Baxter Healthcare Corporation2024-07-03
Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019)Baxter Healthcare Corporation2024-06-06