FDA Product Code PIO: Enteral Specific Transition Connectors
Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors.
Leading manufacturers include Cair Lgl and Jiangsu Caina Medical Co.,Ltd.
9
Total
9
Cleared
188d
Avg days
2014
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Enteral Specific Transition Connectors Devices (Product Code PIO)
9 devices
Cleared
Jan 22, 2024
Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
Cair Lgl
Gastroenterology & Urology
263d
Cleared
Jan 18, 2024
ENFit Adaptor
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology
112d
About Product Code PIO - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PIO since 2014, with 9 receiving FDA clearance (average review time: 188 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
PIO devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →