VIAL DECANTER— 510(k) K852893

Name: FDA 510(k) clearance K852893
Creator: U.S. Food and Drug Administration
Published: 1985-09-20

Substantially Equivalent

Advance Medical Designs, Inc.

FDA 510(k) clearance K852893 for VIAL DECANTER, Substantially Equivalent on 1985-09-20. Applicant: Advance Medical Designs, Inc.. Device class: 2.

Clearance details

Applicant: Advance Medical Designs, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1985-07-09
Decision date: 1985-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.