HORIZON OUTLOOK WITH DOSECOM— 510(k) K011975

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code FRN

Device class

Class 2

Regulation

21 CFR 880.5725

Advisory panel

General Hospital

Date received

2001-06-25

Decision date

2001-09-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carrollton, TX, US

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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-2188-2013 — Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.Class I·Terminated·B Braun Medical, Inc.·20121114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011975.