HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE— 510(k) K141102

Clearance details

Applicant

Hospira, Inc.

Product code

Code FRN

Device class

Class 2

Regulation

21 CFR 880.5725

Advisory panel

General Hospital

Date received

2014-04-29

Decision date

2014-07-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Lake Forest, IL, US

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• K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library2025-07-28
• K242752 — MRidium 3870 MRI Infusion Pump System (3870)2025-05-28

• K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module2017-03-28
• K161036 — Hospira Extension Set, Hospira Primary Set2017-01-06
• K160492 — Hospira Sapphire Sets2016-12-06
• K160870 — Hospira Administration Sets2016-06-01
• K143612 — LifeCare PCA Infusion System2016-04-08

Death

540

Injury

6,178

Malfunction

1,464,165

Other

52

Total

1,470,935

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0195-2018 — ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.Class II·Terminated·ICU Medical Inc·20171030
• Z-2790-2016 — Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.Class II·Terminated·Hospira Inc., A Pfizer Company·20160728

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141102.