KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454— 510(k) K053564

Name: FDA 510(k) clearance K053564
Creator: U.S. Food and Drug Administration
Published: 2006-03-03

Substantially Equivalent

Penlon Limited

FDA 510(k) clearance K053564 for KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454, Substantially Equivalent on 2006-03-03. Applicant: Penlon Limited. Device class: 2.

Clearance details

Applicant: Penlon Limited
Product code: Code CAD
Device class: Class 2
Regulation: 21 CFR 868.5880
Advisory panel: Anesthesiology
Date received: 2005-12-22
Decision date: 2006-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sussex, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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.