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

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.

Clearance details

Applicant: Penlon Limited
Product code: Code CAD
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 ↗

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.