Atlas FDA

Novum IQ Large Volume Pump

FDA 510(k) clearance K211122 · decided 2024-03-29

Clearance details

K-number
K211122
Device name
Novum IQ Large Volume Pump
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2021-04-15
Decision date
2024-03-29
Days to decision
1079 days
Clearance type
Traditional
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 LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump recall (Z-2332-2025)Baxter Healthcare Corporation2025-08-29
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS recall (Z-2173-2025)Baxter Healthcare Corporation2025-08-14
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS recall (Z-1767-2025)Baxter Healthcare Corporation2025-05-20

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