INFUMIX MIXING CONTAINER— 510(k) K870052

Name: FDA 510(k) clearance K870052
Creator: U.S. Food and Drug Administration
Published: 1987-02-27

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K870052 for INFUMIX MIXING CONTAINER, Substantially Equivalent on 1987-02-27. Applicant: Biodynamics Corp.. Device class: 2.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1987-01-07
Decision date: 1987-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.