Atlas FDA

Novum IQ Syringe Pump (40800BAXUS)

FDA 510(k) clearance K242390 · decided 2024-09-05

Clearance details

K-number
K242390
Device name
Novum IQ Syringe Pump (40800BAXUS)
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2024-08-12
Decision date
2024-09-05
Days to decision
24 days
Clearance type
Special
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Deerfield Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump recall (Z-2333-2025)Baxter Healthcare Corporation2025-08-29
Baxter Novum IQ Syringe Pump, product code 40800BAXUS, recall (Z-1964-2025)Baxter Healthcare Corporation2025-06-12
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS recall (Z-1423-2025)Baxter Healthcare Corporation2025-03-21

PMA approvals by this applicant

RecordFirmDate
PerClot® Polysaccharide Hemostatic System (P210036/S008)Baxter Healthcare Corporation2026-08-07
PerClot® Polysaccharide Hemostatic System (P210036/S009)Baxter Healthcare Corporation2026-08-07
PerClot® Polysaccharide Hemostatic System (P210036/S007)Baxter Healthcare Corporation2026-06-08
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