PIO · Class II · 21 CFR 876.5980

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 Medline Industries, Inc., GBUK Group, Ltd. and Cair Lgl.

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
1–9 of 9
Cleared Jan 22, 2024
Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
K231299
Cair Lgl
Gastroenterology & Urology · 263d
Cleared Jan 18, 2024
ENFit Adaptor
K233190
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 112d
Cleared Oct 21, 2022
Enteral Transition Adaptor
K220165
GBUK Group, Ltd.
Gastroenterology & Urology · 274d
Cleared Jul 24, 2015
Medline ENFit Connectors
K151628
Medline Industries, Inc.
Gastroenterology & Urology · 37d

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.