Atlas FDA

BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

FDA 510(k) clearance K133801 · decided 2014-05-07

Clearance details

K-number
K133801
Device name
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2013-12-13
Decision date
2014-05-07
Days to decision
145 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 V6, Model Number 35700BAX recall (Z-2095-2025)Baxter Healthcare Corporation2025-07-17
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX recall (Z-1253-2025)Baxter Healthcare Corporation2025-03-06
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 357 recall (Z-0775-2025)Baxter Healthcare Corporation2024-12-27
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 357 recall (Z-0530-2022)Baxter Healthcare Corporation2022-01-29
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) recall (Z-0121-2021)Baxter Healthcare Corporation2020-10-22
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) recall (Z-0122-2021)Baxter Healthcare Corporation2020-10-22
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Sp recall (Z-1451-2015)Baxter Healthcare Corp2015-04-16

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