PIO
9 FDA 510(k) clearances · Product code
225 daysmedian time to decision
274 days90th percentile
9clearances measured
FDA profile
- Official device name
- Enteral Specific Transition Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
- Adverse events (MAUDE)
- 2015: 119 · 2016: 215
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (K231299) | Cair Lgl | 2024-01-22 |
| ENFit Adaptor (K233190) | Jiangsu Caina Medical Co.,Ltd | 2024-01-18 |
| Enteral Transition Adaptor (K220165) | GBUK Group, Ltd. | 2022-10-21 |
| Cedic Enteral ENFit Transition Connectors (K162254) | Cedic S.R.L. | 2017-05-04 |
| Nutrisafe 2- ENFit Adaptor (K151237) | Vygon | 2016-02-09 |
| Medline ENFit Connectors (K151628) | Medline Industries, Inc. | 2015-07-24 |
| AMT Enteral Transition Adapters (K150034) | Applied Medical Technology, Inc. | 2015-06-09 |
| Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (K150010) | Cedic S.R.L. | 2015-04-02 |
| CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT (K140581) | Cedic S.R.L. | 2014-10-17 |
Track PIO automatically
Every clearance here is in the API, with alerts when new ones post.