DeviceClearance

Product code PIO— Gastroenterology, Urology

AMT Enteral Transition Adapters

Classification name
Enteral Specific Transition Connectors
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
9
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PIO under 21 CFR 876.5980, via openFDA

Market context for product code PIO

FDA has cleared 9 devices under product code PIO between 2014 and 2024, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PIO

Recent clearances under product code PIO

Data sourced from openFDA. This site is unofficial and independent of the FDA.