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 Cedic S.R.L., Applied Medical Technology, Inc. and Vygon.
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
Cleared
Oct 21, 2022
Enteral Transition Adaptor
GBUK Group, Ltd.
Gastroenterology & Urology
274d
Cleared
May 04, 2017
Cedic Enteral ENFit Transition Connectors
Cedic S.R.L.
Gastroenterology & Urology
267d
Cleared
Feb 09, 2016
Nutrisafe 2- ENFit Adaptor
Vygon
Gastroenterology & Urology
274d
Cleared
Jul 24, 2015
Medline ENFit Connectors
Medline Industries, Inc.
Gastroenterology & Urology
37d
Cleared
Jun 09, 2015
AMT Enteral Transition Adapters
Applied Medical Technology, Inc.
Gastroenterology & Urology
151d
Cleared
Apr 02, 2015
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
Cedic S.R.L.
Gastroenterology & Urology
90d
Cleared
Oct 17, 2014
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
Cedic S.R.L.
Gastroenterology & Urology
225d
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.