EVA TPN CONTAINER— 510(k) K041415

Clearance details

Applicant

B.Braun Medical, Inc.

Product code

Code KPE

Device class

Class 2

Regulation

21 CFR 880.5025

Advisory panel

General Hospital

Date received

2004-05-27

Decision date

2004-08-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Allentown, PA, US

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Malfunction

1,000

Other

1

Total

1,001

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-1592-2022 — B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041415.