Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port
FDA 510(k) K140581 · Cedic S.R.L.
510(k) numberK140581
Submission
- Device name
- Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port
- Applicant
- Cedic S.R.L.
Rome, IT - Received
- March 6, 2014
- Decision date
- October 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PIO – Enteral Specific Transition Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Other 510(k)s with product code PIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connectorPIO · Traditional | Cair Lgl | 01/22/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | Jiangsu Caina Medical Co.,Ltd | 01/18/2024SE |
| K220165 | Enteral Transition AdaptorPIO · Traditional | GBUK Group, Ltd. | 10/21/2022SE |
| K162254 | Cedic Enteral ENFit Transition ConnectorsPIO · Traditional | Cedic S.R.L. | 05/04/2017SE |
| K151237 | Nutrisafe 2- ENFit AdaptorPIO · Traditional | Vygon | 02/09/2016SE |
| K151628 | Medline ENFit ConnectorsPIO · Traditional | Medline Industries, Inc. | 07/24/2015SE |
| K150034 | AMT Enteral Transition AdaptersPIO · Traditional | Applied Medical Technology, Inc. | 06/09/2015SE |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIO · Traditional | Cedic S.R.L. | 04/02/2015SE |
More from Cedic S.R.L.
| 510(k) | Device | Decision |
|---|---|---|
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesPIF · Traditional | 04/25/2019SE |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus AdapterPIF · Traditional | 04/09/2019SE |
| K162254 | Cedic Enteral ENFit Transition ConnectorsPIO · Traditional | 05/04/2017SE |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIO · Traditional | 04/02/2015SE |
| K072652 | Enteral Feeding Spike AdapterKNT · Traditional | 01/18/2008SE |
| K042129 | F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer LockFPA · Traditional | 01/27/2005SE |
Questions and answers
When was Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port cleared by the FDA?
Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port (K140581) received a 510(k) decision of Substantially Equivalent on October 17, 2014, 225 days after the submission was received.
What is the product code of K140581?
The FDA product code is PIO – Enteral Specific Transition Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.