PIO

Enteral Specific Transition Connectors

Product code
PIO
Device name
Enteral Specific Transition Connectors
Device class
Class 2
21 CFR
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-01-22.

NumberDecision dateApplicantDevice nameSummary
K2312992024-01-22Cair LglNutricair enteral ENFit adapter: ENFit male – steppe…PDF
K2331902024-01-18Jiangsu Caina Medical Co.,LtdENFit AdaptorPDF

2 summaries are archived here for direct download.

Official FDA classification page: PIO
Classification and pathway per current FDA publications. Data from openFDA (CC0).