Atlas FDA

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

FDA 510(k) clearance K161469 · decided 2017-03-28

Clearance details

K-number
K161469
Device name
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2016-05-27
Decision date
2017-03-28
Days to decision
305 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number recall (Z-2447-2024)ICU Medical Inc2024-08-09
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100 recall (Z-2430-2023)ICU Medical Inc2023-08-18
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number recall (Z-1565-2023)ICU Medical Inc2023-05-16
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infu recall (Z-0171-2020)ICU Medical Inc2019-10-22

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30