Atlas FDA

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

FDA 510(k) clearance K230022 · decided 2023-03-31

Clearance details

K-number
K230022
Device name
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2023-01-04
Decision date
2023-03-31
Days to decision
86 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
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 recall (Z-2096-2025)Baxter Healthcare Corporation2025-07-17
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 357 recall (Z-0776-2025)Baxter Healthcare Corporation2024-12-27
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of recall (Z-2581-2024)Baxter Healthcare Corporation2024-08-16
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 recall (Z-2530-2024)Baxter Healthcare Corporation2024-08-07
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 recall (Z-2103-2023)Baxter Healthcare Corporation2023-07-13

PMA approvals by this applicant

RecordFirmDate
Preveleak Surgical Sealant (P100030/S021)Baxter Healthcare Corporation2025-07-10
PerClot® Polysaccharide Hemostatic System (P210036/S005)Baxter Healthcare Corporation2025-04-25
Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020)Baxter Healthcare Corporation2025-04-11
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