PIO
- 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231299 | 2024-01-22 | Cair Lgl | Nutricair enteral ENFit adapter: ENFit male steppe… | |
| K233190 | 2024-01-18 | Jiangsu Caina Medical Co.,Ltd | ENFit Adaptor |
Official FDA classification page: PIO
Classification and pathway per current FDA publications. Data from openFDA (CC0).